PV Strategy and Roadmap
Case management (ICSR processing and reporting)
Clinical study execution (Study doc review)
Study maintenance support (Queries, Site training)
Risk management & mitigation activities
Signal detection
Key safety governance contributions
Development and management of controlled documentation (Policy/SOP/WI)
Inspection readiness activities
Performance and compliance metrics
Vendor and partner alliance management and oversight
Audit support
Help define strategy for selecting and choosing PV System
Selection and management of Safety database vendor
Data analytics tool selection and support
PV Strategy and Roadmap
Case management (ICSR processing and reporting)
Clinical study execution (Study doc review)
Study maintenance support (Queries, Site training)
Risk management & mitigation activities
Signal detection
Key safety governance contributions
Help define strategy for selecting and choosing PV System
Selection and management of Safety database vendor
Data analytics tool selection and support
Development and management of controlled documentation (Policy/SOP/WI)
Inspection readiness activities
Performance and compliance metrics
Vendor and partner alliance management and oversight
Audit support
clients
worldwide
products
supported
global
staff
years average
PV experience
Bethany Van Veen has focused her entire career on pharmacovigilance (PV). Starting in the late 1990s, she began her PV career in drug safety operations at Elan Pharmaceuticals and continued to hold a variety of operational leadership roles within small and large organizations including Johnson & Johnson, Millennium Pharmaceuticals and InterMune. In her role as Head of PV Operations at Intermune she built the PV infrastructure to support the company’s first global product launch. She began her consulting career in 2013 as a strategic PV advisor to organizations such as Jazz Pharmaceuticals, Exelixis, Onyx Pharmaceuticals, Medivation and Juno Therapeutics where she supported business process optimization, change management, implementation of new regulations, partner and regulator inspections, REMS improvements and preparation for commercialization. In her consulting career she has advised over 75 companies and has seen dramatic shifts in PV methodology and she values the importance of leveraging strong PV foundational skills to curate new ways of meeting global PV challenges.
In 2017, she founded Perspective Pharmacovigilance, a think tank of PV experts. PPV’s global staff of industry leaders, former PV department heads, and ex-regulators, design innovative solutions to a rapidly changing PV landscape. Bethany is passionate about cultivating PPV’s unique environment where the global team can do the work they love with people they trust.
Bethany is also an adjunct professor at San Francisco State University teaching the Safety Monitoring Course for the Clinical Trials Design and Management Certification.
Evan Blander was previously the Vice President, Drug Safety at Exelixis, Inc. For over five years he was responsible for overseeing Drug Safety Operations, Quality Management, and Drug Safety Systems at Exelixis. Prior to Exelixis, Mr. Blander was the Director, Drug Safety Systems and Quality Management at Onyx Pharmaceuticals until it was acquired three years later by Amgen, Inc. Previous to his work at Onyx Pharmaceuticals, Mr. Blander held multiple roles at Amgen Inc. spanning the drug development life cycle from research and pre-clinical, through to clinical development and commercial manufacturing and was heavily focused on Information Systems before transitioning to Global Regulatory Affairs and Safety (GRAAS). Mr. Blander began his career holding multiple positions at IBRD-Rostrum Global. He graduated California State University, Northridge with a Bachelors of Science in Mathematical Statistics and UCLA with a Masters of Science in Biostatistics.
Lee Chaiken has over 30 years’ experience in pharmacovigilance (PV) primarily in executive leadership and operations management in both large and small CROs. Prior to joining Perspective PV, Lee was the Sr. VP/General Manager of PrimeVigilance USA with oversight of global Medical Information and PV USA, she served as Sr. VP of Ashfield PV, and held various PV operational oversight positions within Quintiles/IQVIA where she participated in the establishment of Quintiles’ first Drug Safety department, initial establishment of the PV India operations and spent several years working in IT with the Argus Safety platform. Lee is based in North Carolina.
Ariela Chick has worked in Pharmacovigilance for over 20 years and has held leadership roles in global safety operations, PV training & compliance, safety vendor management and REMS/PASS program management. She has built and managed PV functional teams for over 15 years and has supported various global PV regulatory inspections (FDA, MHRA, CFDA and Health Canada) at various companies such as Amylin (now BMS), BioMarin, Gilead Sciences, and most recently BeiGene. Ariela enjoys working collaboratively across global teams to prepare for the increased regulatory and business demands that come with entry into the commercial phase, including set up and maintenance of a PSMF. Ariela earned her Bachelor of Science degree in Biological Sciences at UC Irvine, followed by her Master's in Public Health (Infectious Diseases) at UC Berkeley. Prior to working in Pharmacovigilance, Ariela gained experience in infectious disease epidemiologic research in both Brazil and in the US.
Cecilio "CJ" Delgra, MD has developed significant experience is safety case management and operations, medical review, clinical trial safety, global regulatory inspection management, safety vendor quality oversight and outsourcing, process development, safety CAPA management, and REMS Operations oversight during his time within safety departments as several global biopharmaceutical companies. Over the past 22 years, CJ has served in various leadership roles within global safety organizations at Celgene/BMS, Merck, Amgen, Genentech/Roche, and Kendle International (now Syneos) and led teams in Colombia, Switzerland, UK, Japan, China, India, Canada and across the US. He has led safety integrations of acquired companies and additionally led transition of safety information of divested products. CJ has been active with TransCelerate PV projects, and a past speaker at the American Society of Clinical Oncology and the LUNGevity Foundation round table on compliance with the FDA "Final Rule" and reducing uninformative IND Safety Reports to FDA and investigators. Most recently, CJ was the VP Individual Case Management, Medical Review, Aggregate Safety Reporting and Clinical Trials Safety Management at BeiGene Global Patient Safety where he led a group of 80 located across the US and China.
Josée Moon has over 20 years of industry experience including 18+ years of Drug Safety/Patient Safety experience in various leadership and management roles such as Director of Safety and Risk Management departments and Head of Global Patient Safety Surveillance of a large global CRO providing strategic advice regarding key safety and risk management strategies in both pre and post marketing scenarios. Josée has also worked in various individual contributor roles such as Lead Drug Safety Associate, Safety Project Manager, and Safety Scientist which has provided hands on experience and full understanding of safety processes. She has also developed extensive vendor management experience with an emphasis on quality deliverables as well as process development experience focusing on building efficient pharmacovigilance processes. Over her many years in pharmacovigilance, Josée has developed expertise in building custom safety surveillance strategies to best fit organizational needs and tailor risk management systems to address specific risks and safety profiles of individual products. Josée also has a passion for pharmacovigilance system development, implementation and validation, bringing solutions to the industry that brings patient safety to the forefront with new innovative technologies.
Karen Truhe has worked in safety and pharmacovigilance for more than 20 years, including 10+ years in drug safety management in small and large pharmaceutical companies. Most recently, Karen was Head of Safety & Pharmacovigilance at Cidara Therapeutics. Karen also held leadership roles at Valeant Pharmaceuticals, CV Therapeutics (acquired by Gilead Sciences) and Johnson & Johnson. Additionally, she worked as an independent PV consultant for 7 years supporting clinical stage pharmaceutical companies with inspection readiness activities, business process development, alliance management and vendor oversight. Karen holds a BS in Cell and Molecular Biology from Tulane University and a Master of Public Health degree from Tulane School of Public Health and Tropical Medicine.
Marisa Fernandes has over 23 years of clinical research experience as a study coordinator, study nurse and within the CRO industry, with 16 years specifically focused on Drug Safety - pharmacovigilance and regulatory requirements for safety submissions in Latin America and the United States. Most recently, Marisa was the Director, Drug Safety Center overseeing Pharmacovigilance and Patient Safety DSC in Charlottesville-VA, USA, and São Paulo, Brazil, for a global CRO. Prior to this position, she was a Drug Safety Associate at 2 different global CROs; responsible for safety services in post-marketing and clinical trials (primarily Oncology). Marisa obtained her Bachelor of Science in Nursing at the Federal University of São Paulo in 1998. Her nursing experience includes several positions within São Paulo from nurse in charge to staff nurse in the Emergency and Intensive Care Unit as well as Outpatient Chemotherapy service, to senior study coordinator and study nurse at Hospital do Câncer – A.C.Camargo and GPMed – São Paulo. Marisa is natively fluent in Portuguese and fluent in English and Spanish.
Alyssa is a registered nurse that started her career at the patient's bedside in the Trauma/Surgical ICU. She changed her career path to Pharmacovigilance over 25 years ago and has worked in large and small pharmaceutical companies, CRO’s and consultant positions with both clinical trial and post-marketing products primarily in the oncology space. Alyssa’s experience includes case processing, regulatory report writing, signal management, quality review and safety management team activities. In her downtime, she loves going to the gym, watching her daughter play sports, and spending time with her 3 children, husband and 3 dogs. Alyssa is located in NJ but also spends time in coastal NC.
Amie Natali has 16 years of experience in the clinical research industry focused on Drug Safety – Pharmacovigilance, clinical trial case processing through to global regulatory reporting, within many indications. Amie has six years management experience in both project and direct line management. She served as a Senior Drug Safety Manager where she functioned as an SME overseeing a regulatory reporting portfolio for a large pharmaceutical company. Prior to management, Amie functioned as a Drug Safety Associate managing the day-to-day safety operations focusing more within the smaller biotech companies where she managed study start-up activities, document ownership, configuring of safety systems, ICSR processing, regulatory reporting, aggregate reporting, through to study close out. She has contributed to SOP development and training initiatives, with additional experience in inspection readiness. She currently functions as a PV Operations lead working with small to mid-sized pharmaceutical companies build their PV infrastructure. Amie is a registered nurse, primarily focused within the Intensive Care Unit. Amie is based in Montgomery County, PA 20 miles outside Philadelphia.
Ana Cooper has over 14 years of experience in Clinical Trials and the Pharmaceutical Industry in Brazil and in the US, with over 9 years of direct Pharmacovigilance experience.
Ana started her Pharma career as a Medical Information Specialist at Pfizer – Brazil. She then served as Drug Safety Associate/Specialist at two different global CROs in the US where she has held various leadership roles such as Lead Drug Safety Associate and Safety Operations Manager. These roles have provided her with hands on experience and understanding of all aspects of full-service clinical trial case processing, global safety regulatory reporting, Safety Management Plans writing, Inspection readiness, Safety Database setup, training and onboarding with exceptional work ethic and a strong commitment to quality. Most recently, Ana was a Line Manager at the Safety Operations Unit in the Lifecycle Safety Department for a large global CRO. Ana has direct leadership and oversight experience in a large portfolio of global studies in several different therapeutic areas, such as infectious disease (including COVID), oncology, diabetes and cardiovascular diseases.
Ana holds a Master’s degree in Business Administration from Escola Superior Aberta Brasileira and a Bachelor of Science in Pharmaceutical Sciences (BSPS) from Universidade Estadual Paulista. Ana is fluent in English, Portuguese, and Spanish. She is currently based in Charlottesville, VA.
Angela Aguas MD, has over 20+ years of pharmacovigilance experience, started in clinical trial operations/data management at a CRO for 5 years, then significantly contributed 15 years at Amgen within the safety department responsible for aggregate review, safety surveillance, signal detection, case management, database transition initiative, vendor management and outsourcing, regulatory inspection and CAPA management, and later, served as the head of the medical safety review team. Prior to joining PPV, I transitioned to a PV consultant role at Beigene, contributed to the development of various process improvement initiatives in medical review and case management including PV inspection readiness.
Benton Brown has been in biotech for the past 25+ years. Intially starting out for Quitiles in Roslyn, VA, Benton then joined a series of biotech companies over the years including Ares Serono in the greater Boston area, Amgen in southern California, Genentech in northern California and then Celgene in New Jersey. After Celgene’s acquisition by BMS, he moved into pharmacovigilance consulting in late 2021. Throughout his career, he focused mostly within the oncology space and worked on several of the most successful oncology products ever developed, including Epogen, Aranesp, Neupogen, Neulasta, Avastin, Revlimid and Pomalyst. His primary focus over the past 15+ years has been working on NDA/BLA/MAA submissions globally, guiding the strategies for the safety data presentations and then responding to health authority questions during the review. In addition, he has spent quite a bit of time on the initial period shortly after marketing authorization to identify new safety signals and to lead updates to the product language accordingly. Benton has a BA in Biochemistry from University of Arkansas and an MD in Medicine from the University of Arkansas for Medical Sciences, College of Medicine.
Bridget Wagner has been in clinical research for over 30 years; having worked has an investigator for H.I.V. Aids drugs for 7 years and was fortunate to have witnessed many of the breakthrough medications. Bridget joined Biotech working at Genentech in the clinical safety department. At one stage she claimed to have worked on almost all the approved drugs at Genentech, that is before it became an independent subsidiary of Roche, including Rituxan (oncology and autoimmune), Herceptin, Avastin, Nutropin and Xolair. Throughout her career she has worked in numerous therapeutical areas. Her main focus was in autoimmune disease and oncology, including both small and large molecules. She has extensive experience in safety across all stages of product development and clinical trial design (Phase I through post-marketing). She has represented safety at numerous meetings with regulatory authority s including the FDA , EMEA, Health Canada and MRHA. These have included NDA/BLA, End of Phase II, through to market authorization and post marketing signal detection. Recently she worked with the EMEA to develop strategies to monitor safety in pediatric oncology and alpha tested MOdified NARanjo Causality Scale (MONARCSi): A Decision Support Tool for Safety Scientists for safety label for filling.
Bridget received her medical degree from the Royal London Hospital UK and was a fellow at UCSF.
Carla McCardell has 16+ years of experience in the clinical research industry, focused on pharmacovigilance and drug safety in various individual contributor, leadership, and management roles at a large global contract research organization (CRO). Specialized experience in safety sciences and risk management, including coordination of aggregate safety data reviews, safety surveillance, signal management and signal detection activities, authoring aggregate safety reports, conducting literature search and review, and providing support for the development and maintenance of core safety information (CSI) and reference safety information (RSI). Extensive experience in pharmacovigilance operations and oversight of clinical trials in the therapeutic indications of oncology, hematology, and immunology, as well as leading clinical trial PV activities such as authoring Safety Management Plans, management of the safety sections of study-related documents (IB, ICF, protocol, etc.), implementing and maintaining pharmacovigilance infrastructure to support clinical trials of all phases, and inspection readiness activities. Experienced contributor in initiatives to support new or enhanced Pharmacovigilance and Patient Safety processes and best practices. Carla is a research scientist by training, with a B.S. in Biology and a M.S. in Medical Microbiology and Immunology. She is based in Charlottesville, VA.
Carolina Silveira is a nurse by training and has over 10 years of industry experience starting off as a study coordinator before starting her PV career. She has an extensive background in case management, SOP development support, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance and PV personnel management. Carolina is natively fluent in Portuguese, fluent in English and Spanish and is based in Charlottesville, VA.
Claudia Mano is a board certified in internal medicine and endocrinology and MS in Head and Neck Surgery focusing specifically on thyroid. She has over 25 years of clinical experience in endocrinology and cardio-metabolic, with a special emphasis on diabetes 1 and 2 and pediatrics. She has extensive knowledge (more than 20 years) in global trials as a medical director with a specific focus on endocrinology as well as other therapeutic areas like inflammatory and infectious diseases, CNS, rare diseases, ophthalmology, internal medicine, oncology, immunology as well as pediatric trials. Her previous experience encompasses developing Safety Development Plans, Pharmacovigilance Plans, Risk Management Programs including design and conduct of safety studies, reviewing case narratives. Claudia maintains close relationships with investigators in different therapeutic areas in Latin America and US. Professor for endocrinology at medical school, extensive teaching experience on diabetes for residents and medical school students. Her post-graduation course focused on Patient Experience and Person-Centered Care at Hospital Sirio Libanes in São Paulo.
David has over 25 years of experience in the biotechnology industry. Previously he was a Senior Director of Quality Assurance at Exelixis Inc. for just under 7 years, where his responsibilities included supporting Global Patient Safety, a QA representative on Phase I and III clinical studies, and Business Process Owner for computer system validation, process maturity, and data integrity across the organization. He was also responsible for conducting audits of Exelixis’ GxP vendors and business partners.
David began in offshore private banking at Coutts & Co in Jersey. He made a switch to biotechnology in the late 90s, to Amgen Inc., where he worked for 15 years, in Clinical Data Management then GxP Compliance. He then moved into Pharmacovigilance (PV) Compliance, first at Onyx Pharmaceuticals (until it was acquired by Amgen two years later), then Medivation Inc. (until it was acquired by Pfizer Inc. two years later). In both corporations he was responsible for management of the PV Quality System, compliance oversight and metrics, and vendor management.
He graduated with Honors from Salford University in the UK with a Bachelor of Science in Mathematics, then obtained a Postgraduate Diploma in Quality Management from Humberside Business School and an MBA (with a concentration on Leadership and Managing Organizational Change) from Pepperdine University.
Emilie Brezman has worked in pharmacovigilance (PV) for over 18 years primarily in operations and PV project management, leading diverse PV projects including implementing and enhancing systems to improve adherence to quality standards, executing interdepartmental audits and actuating process changes, as well as long term strategic planning. She has extensive experience in supporting clients' PV operational needs during drug development and beyond as well as facilitating the selection, configuration and implementation of safety systems. Prior to her work at PPV, Emilie lead the integration of Onyx Drug Safety/Pharmacovigilance and Regulatory Affairs functions into Amgen's Global Regulatory Affairs and Safety organization and held various operations positions at Onyx Pharmaceuticals, Elan Pharmaceuticals, and Actelion Pharmaceuticals.
Gary Bloomgren, MD, MBA has served in multiple drug safety strategy/leadership roles across numerous therapeutic areas, both within small and large biotech/pharma companies. In addition to a passion for building and developing productive leadership teams, he has led innovative drug-safety signal investigation and benefit-risk strategies that help inform stakeholder decision-making. An example of this includes the development of a risk stratification algorithm for patients to make informed treatment decisions based on their risk for developing Progressive Multifocal Leukoencephalopathy (PML), a rare brain infection associated with use of Tysabri. Over the last 20+ years, Gary has held medical safety leadership roles at Amylin (now BMS), Biogen, and most recently Alkermes. As a part of his leadership responsibilities, he has presented to regulators at the FDA, Health Canada and EMEA, and presented on numerous drug safety topics at major pharma and drug safety venues in both Europe and North America. For the past several years, Gary has provided drug safety consulting for clients on topics such as governance, SOPs, leadership development, safety signal investigation, in-licensing safety due-diligence and preparation for regulatory interactions.
Giovanna Marins graduated nursing in 2010 and concluded her post degree in clinical research in 2011. She has over 11 years of experience in the pharmaceutical industry, specifically pharmacovigilance and the reporting of the Serious Adverse Events. In addtion, she has a experience as a Clinical Research Study Coordinator on pediatric oncology studies two years of experience in a pharmaceutical company as a Pharmacovigilance Analyst with post marketing, seven years of experience as Drug Safety Associate including cardiometabolic diseases, oncology, immunology, hematology, neurology, infectious diseases (vaccine), and gastroenterology therapeutic areas. Recently she has been a consultant supporting clients’ PV operational needs during drug development. Giovanna has a Bachelor of Nursing and is fluent in Portuguese and English.
Jen Tessendorf has over 10 years clinical trial experience working for several large contract research organizations (CROs) overseeing all phases of PV and clinical trial projects from startup to closeout, including extensive post-marketing experience. As a Senior Safety Associate and a Senior Safety Project Manager, Jen has direct experience leading large global teams in ICSR case processing, aggregate reporting, expedited reporting, SAE-AE reconciliation and many other aspects of PV operations. In addition to her PV experience, Jen’s clinical project management background brings valuable insight into PV related cross-functional service touchpoints within clinical operations, data management, and medical monitoring. Jen has a strong focus on clear communications with internal and external stakeholders to provide high quality and timely deliverables. Jen earned her BS in Biology from the University of Virginia, MS in Health Administration from Virginia Commonwealth University, and is a PMI certified Project Management Professional. Jen is located in Charlottesville, VA.
Jocelyn Blander is a junior project manager and over the past years she has worked to develop her project management and website development skills, supporting various Perspective PV projects. Jocelyn has successfully implemented project management tools and dashboards to facilitate PV management of critical deliverables supporting project initiation to global PV launch readiness, and SOP development. Jocelyn spearheaded the design for Perspective PV intranet site, as well as reorganized the team’s various procedural documents and educational materials and templates. She earned her Bachelor of Science at the University of Kansas in Behavioral Neuroscience with a minor in Astrobiology.
Joelle Smith has 14+ years of experience in clinical research, both in pharmacovigilance and regulatory writing, with several years of additional project management in the hospital/healthcare environment. Joelle started her career as a drug safety associate, advancing to drug safety project manager at three global CROs. She has experience working across numerous therapeutic areas. Joelle has managed large portfolios with multiple indications, covering sites in 30+ countries. She has directed all aspects of safety activities for clinical trials from start-up through close-out. Her regulatory writing experience includes authoring safety documentation and regulatory responses for a big pharma Covid-19 vaccine, as well as aggregate reports (DSURs and PSURs), and quality document review. She maintains strong customer relationships through open communication and responsiveness. Joelle graduated summa cum laude with a master's degree in health and wellness. She is based on the east coast near Asheville, NC.
Kathryn Jerabek is a health researcher with a Master of Public Health degree in Biostatistics & Epidemiology and Infectious Diseases from Boston University, and BA in Psychology from the University of Colorado, Boulder. Kathryn has an appreciation for all biological, sociopolitical, and economic determinants of health. She believes that health occurs at the intersection of these factors, and improving the health of individuals and populations requires a collaborative, interdisciplinary, and holistic understanding of health. As a pharmacovigilance health researcher working primarily in clinical trial safety management, she has paired her expertise of biostatistical and epidemiological methods with her appreciation for social determinants of health, allowing her an evidence-based and patient-centered approach towards ensuring the safety of clinical trial patients.
Lee Anne is an RN with 12 + years of patient care experience, primarily in pediatric oncology, and 20 + years of post marketing and clinical trial Pharmacovigilance (PV) experience with large to small pharmaceutical and biotech companies including J&J, Jazz Pharmaceuticals, Forty Seven, Inc. and Loxo Oncology at Lilly. She has held positions of increasing responsibility in PV Operations and Case processing where she has been responsible for oversight of PV processes including day to day operations and oversight of PV vendors, development and delivery of clinical study report safety narratives, development of Standard Operating Procedures, and management and mentoring of direct reports.
Lori Fox has a diverse background which includes a combination of healthcare, clinical research, government agency and business industry experiences. After 17 years working in corporate America and federal government in positions of increasing responsibility, Lori transitioned into the healthcare industry by becoming a Registered Nurse in an acute care hospital setting. In 2015, she gravitated towards clinical research as a Clinical Research RN at the University of Colorado Cancer Center Clinical Trials office where she served on the Breast Cancer team. After gaining clinical research site experience, she entered the CRO world. Lori held senior positions with three large global CROs where she gained experience in case processing, quality control, query management and SAE reconciliation. In 2019, Lori began working as Manager, Drug Safety and Pharmacovigilance at Odonate Therapeutics (breast cancer). Prior to joining Perspective Pharmacovigilance, she was Manager, PV Operations at Deciphera Therapeutics (gastrointestinal cancer). Lori brings extensive experience in PV Operations, study leadership, business process optimization and process efficiencies, workflow management, safety vendor oversight, SAE reconciliation, safety database migration, and all aspects of ICSR processing. Most recently, she has been involved in gap analysis, SOP development projects, and audits. In addition to a Bachelor of Science degree in Nursing, she also holds a Bachelor of Science in Business Administration degree and a Master’s degree in Business Administration.
20+ years of experience in drug safety and pharmacovigilance working at small to medium biotech companies and drug safety technology companies. Her experience over the years has focused on supporting and managing Safety Systems, Safety Operations and Compliance Management functions. In recent years she has led system implementation, PV Vendor transition, Gap Analysis and SOP development projects. Throughout her experience, Maria has enjoyed managing and mentoring new staff. Maria is base in San Francisco, CA.
Marilyn Proulx her experience in research at Dana Farber Cancer Institute in Boston, MA in both Hematologic Oncology and Breast Oncology. She pursued her passion of clinical trial work by moving into industry after nearly five years at DFCI. She quickly found Drug Safety within smaller biotech companies and was able to contribute to various functions to help her teams. Over her 15 years in the industry, Marilyn has developed expertise in Drug Safety Operations, Vendor Oversight, Quality and Compliance, Business Process Optimization, and Audit/Regulatory Inspection Preparedness.
MaryJean Pendleton began her research career in 2010 where she studied breast cancer and leukemia at the bench for 5 years. She subsequently transitioned to the pharmaceutical industry where she held roles in drug safety operations at two global CROs. Most recently, she served as an Associate Manager of Drug Safety and Pharmacovigilance at Odonate Therapeutics. She has managed the start-up and maintenance of pharmacovigilance activities spanning from early phase to phase IV clinical trials. MaryJean has extensive experience in safety activities for oncology and rare disease studies, focusing on SAE case processing, expedited reporting, and quality oversight. MaryJean holds a BS in Biology from Loyola University and a MS in Biochemistry from Vanderbilt University. She is based in Charlottesville, VA.
Monica Nolan has worked within drug safety operations for the last 19 years for both small and medium-sized pharmaceutical and biotech companies as well as within a safety management organization providing safety support for multiple clients. She has experience in both post-marketing and clinical trial case processing and quality review. As a clinical trial safety lead, she was involved in study start-up, SAE reconciliation and query management. Throughout her drug safety experience, Monica has served as a mentor to new staff, as well as a contributor to PV process improvement and SOP refinement. Monica holds a Bachelor of Science degree in Nursing from The College of New Jersey and Master of Science degree in Bioethics from St. Thomas University in Miami Lakes, FL. Prior to joining industry, she served in the US Navy Nurse Corps working in oncology and emergency medicine. She transferred her commission to the US Public Health Service serving at the National Institutes of Health with a focus on neurologic/neurosurgical clinical trials.
Oleksandr Karpenko is a pharmaceutical physician, clinical and medical safety consultant and MD with Olexacon (London, UK). In his consulting projects Oleksandr leverages expertise and skills gained over 19 year of hands-on and management experience with Roche, AstraZeneca, Sanofi, Takeda, Servier and other companies. He has worked in medical capacity at various levels in global drug safety, from affiliate PV, global safety operations to global safety lead and therapeutic area head responsibility from preclinical to various stages of clinical and post marketing safety surveillance. His industry therapeutic expertise includes oncology, gastroenterology, respiratory, metabolism, inflammation, and other areas. Oleksandr has MBA and MD degrees from Kyiv, Ukraine, with initial medical specialization in orthopedics and traumatology, including 4 years of practicing medicine, licensed for practice in the UK. Oleksandr provides medical contribution to a range of services, including organizational design, PV-related processes and procedures, medical monitoring and data review, safety oversight of investigational and marketed products, signal detection and evaluation, risk management, safety contribution to design of clinical development programs and individual clinical trials, contribution to pertinent clinical documents and reports (IB, IMPD, study protocol, ICF, CRF, clinical study reports etc.) processes and decision criteria (safety reporting, stopping rules, go-no go criteria etc.), Data Monitoring Committees, training of investigators and service provider personnel. Oleksandr also leads from the medical safety perspective regulatory submissions (NDA, BLA, marketing authorization applications), periodic and aggregate reports (PSUR/PBRER, DSUR, CTD 2.5 and 2.7.4, ACO, PADER etc.), as well as Risk Management Plans (RMPs), responses to regulatory requests and other regulatory interactions, ICSR medical review and other services.
Patricia Fioratti has 15 years of experience in Clinical Trials, being 5 years as Clinical Research Associate for phase 1, 2 and 3 studies in several therapeutic areas, and 9 years in Pharmacovigilance, that includes 8 years as Drug Safety Associate for phase I, II and III studies, being project leader, which includes team management, management of metrics and compliance of studies, case processing in safety database (ARGUS) and submission of reports to regulatory agencies and research sites within the deadlines stipulated in current legislation. She has 6 months of experience as Drug Safety Center Supervisor, that provided support for career development as Functional Manager for a group of Drug Safety Associates (DSAs) and support to DSAs on their projects related tasks, and supports development of SMPs, SOPs, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance. She also has over 6 months as a PV Consultant, providing support to clients in PV tasks, that includes SAE/AESI/SUSARs processing, query management and study management.
Paula Freitas is a nurse by training and has over 15 years of Clinical Research experience, specifically focused on Drug Safety, working as Drug Safety Associate and Drug Safety Project Manager for two different large global contract research organizations (CROs). Her responsibilities included several safety services in phase I to III global clinical trials, including but not limited to leadership and management of global or regional projects, oversight of the receipt and processing of all adverse event reports and expedited safety reports, authorship of Safety Management Plans, and development of training courses, SOPs and associated documents, with additional experience in participating in PV audits, safety regulatory compliance and configuration and implementation of Drug Safety Systems such as ARGUS Safety Database for projects. She has an extensive experience with systems such as Medidata RAVE, IVRS, Oracle AERS and ARGUS and eTMF (NextDocs and Veeva Vault), and has worked in many different therapeutic areas. As a Registered Nurse (RN), Paula has worked in Inpatient ward unit and hemodinamics for 3 years before joining the Clinical Research team. Paula is natively fluent in Portuguese, fluent in English and is based in São Paulo, Brazil.
Prabjot Hunjan has over 17 years of PV experience both in CROs and pharma. Prabjot also spent 6 years in management within a leading UK ophthalmology chain.
Prabjot’s CRO & pharma experience includes director-level management where he managed and developed the Pharmacovigilance function through strong leadership and supervisory skills in spearheading Pharmacovigilance Quality and Process Improvement in those roles. He has also acted as EU QPPV and Deputy on behalf of Marketing Authorization Holders in the EU. Most recently Prabjot’s experience included working within a large team as a program and product lead on a well-established MS product within pharma. Prabjot brings valuable experience both in clinical trial and post-marketing within European and Global PV operations including PV systems, database validation and security, PV QMS, Benefit-risk management, Signal Detection & Management, periodic reports, Inspections, PSMF, EudraVigilance and as EU QPPV (and Deputy). He is also a trained auditor and experienced in EU GDPR as a Data Protection Officer.
Prabjot has a BSc in Pharmaceutical Sciences from Kingston University UK and a Post graduate certificate in Pharmaceutical Medicine from the University of Surrey UK.
Ramil Cabela, DBA, MBA, BSN, RN has worked in pharmacovigilance for over 20 years helping pharmaceutical companies develop high-performing teams and implement innovative systems and processes in drug safety. He has held managerial and leadership roles in global safety operations, PV training, compliance & quality management, as well as PV sciences. At Pfizer’s consumer health division, he helped build its first electronic project management system for aggregate safety reports and led a team of specialists managing PV quality, training, and compliance. He also collaborated with IT professionals in developing and implementing a safety case management quality assurance database that helped track and document ICSR quality metrics. At Celgene, he led a case management team for several years and was responsible for the successful transformation of the company’s paper-based case management to 100% electronic process, with improved case narrative quality through Six-Sigma implementation (results published in iSixSigma Magazine). He then led Celgene’s team of PV scientists in managing the safety surveillance and benefit-risk assessments of its marketed and pre-market products. His collaborations with IT safety experts and multidisciplinary PV business teams allowed him to help design and implement Celgene’s safety signal detection and management systems and processes. At Bristol Myers Squibb, he was Head of Safety Science in hematology-oncology and cell therapy and co-led the integration of teams, systems, and processes in safety signal detection and management. Ramil is a trained critical care nurse who earned his Bachelor of Science in Nursing degree from the University of the Philippines. He has a Master’s degree in Business Administration from the City University of New York, and a Doctor of Business Administration from the University of South Florida. In his spare time, he loves to play tennis, swim, sing, play the piano, and travel to new places every year with his wife who is a family medicine physician in New Jersey.
Regiane Santos has 13 years of experience in the Contract Research Organization (CRO) Industry as a Drug Safety Associate II (DSA 2) and in global regulated environments. Previous experience included clinical research analyst (CRA) at Pharma Company for 4 years in Clinical Trial Management of monitoring activities. Regiane responsibilities include case processing and regulatory submission support to the regulatory authority (Latin America, USA, and Europe region), sites, and Ethics committee. Good knowledge of ARGUS, Intralinks, Veeva Vault, SafetyVigilance, EDC Medidata RAVE. Advanced Microsoft Office knowledge, Advanced Microsoft Internet Explorer Knowledge, Oracle RDC, Clinical Trials Management System (CTMS), Electronic Trial Master File (eTMF), and BOX. Therapeutic experience includes. Endocrine/Metabolic: Diabetes, Overactive Bladder Syndrome (OAB), Musculoskeletal: Osteoporosis, Osteopenia Postmenopausal Women, Rheumatoid Arthritis, Transplants: kidney transplantation and Oncology (Close-out), No interventional study. Regiane is very organized, focused on the study goals, and an easygoing person. Awarded with a Yellow belt to Continuous Improvement Project, Member of the Monitoring Committee.
Sharon Marchessault has 20 years of DrugSafety/Pharmacovigilance experience (US, EU and ROW) working on both thesponsor and service provider side for oncology, neuro, pain management, and cardio companies. Inaddition, she spent the first 8 years of her career working as a R&Dlaboratory scientist (Syntex, inc. and Galileo Pharmaceuticals). Sharon has extensive experience with avariety of PV clinical and post marketed activities including safety systemimplementation, clinical study reconciliation, compliance and audit readiness,case processing, MedDRA coding, application submissions, aggregate reports, andcreating and verifying reports for internal (upper management metrics etc.) andexternal (agency and partner) use. An experienced project manager, Sharonenjoys building business partner (SDEAs/Collaborations) and vendorrelationships, maintaining intra and interdepartmental communication, mentoringstaff and establishing candid and direct communication with executivemanagement.
Susan has been working in Pharmacovigilance for over 20 years. She worked in the biotech industry in roles with increasing responsibility in the areas of individual case safety report management, aggregate reporting, vendor and alliance management, compliance, and training. Susan left industry in 2013 to open a PV consulting business specializing in compliance and inspection-readiness. She is well-versed in gap assessments and process optimization, auditing, and establishing and managing PV Quality Systems. Susan utilizes her comprehensive knowledge of regulatory requirements and industry best practices to deliver tailored solutions to client needs. Susan holds a Bachelor of Science degree from Cornell University and a Master of Public Health degree from the University of California, Berkeley.
Tatiane has been in pharmacovigilance for more than 14 years with over 10 years of industry experience and 9 years focused on safety activities in Latin America. Prior to her consulting work, she held safety positions at Johnson & Johnson, Merck (EMD Serono in US) and Abbott as a safety associate for full PV activities, triage, case processing, quality check, submission, follow-up, query management, PV representative for some Latin America countries. She also has additional experience in literature search, screening of health authority websites, Argus Safety Database, and Vigiflow. She graduated from Sao Paulo State University (USP) with a Bachelor of Pharmacy and Biochemistry and ESPM with a Master of Business Management. She is native in Portuguese and fluent in Spanish.
Tina earned her BSN degree from Temple University and did some post graduate studies at George Washington University. After working as a nurse at Thomas Jefferson University and the University of Pennsylvania in the MRICU and CTSICU respectively, she moved to CA where she worked in research as a Clinical Trials Manager for Neurology/Psychiatry and Oncology. Tina moved to the Thousand Oaks area and worked at Amgen for 16 years in Early Development, Case Processing, and Medical Review before moving into TA Safety Pharmacovigilance. She recently left Arrowhead Pharmaceuticals, where she was an Associate Director in Drug Safety Operations.
Cathleen Sobajian is the Senior Accountant at PPV. Prior to joining PPV, Cathleen worked as an accounting manager for a fiduciary firm and handled the financial reporting for trust and probate administrations, as well as the company financials. She holds a degree in Business Administration from CSU, Sacramento and is based in northern California.
Jaime Mitchell is the Controller at PPV and is a Certified Public Accountant with 20+ years of experience in accounting and finance. Jaime was recently the CFO for a multi-million-dollar, 174-bed Joint Commission accredited hospital responsible for all financial operations including Accounting, FP&A, Supply Chain Management, Revenue-cycle operations and Compliance. Prior to this she held leadership positions in multi-million-dollar organizations in coal mining, power generation and manufacturing. She built a solid foundation early on with years of auditing and tax return preparation work. Throughout her career Jaime has built a reputation for being a top leader in developing and executing strategic FP&A, driving vigorous revenue management initiatives, creating robust budgeting and forecasting models, standardizing and streamlining accounting processes and scaling best-in-class financial operations.
Kevin has over 17 years of experience in many business development and project management roles, mainly in the technology start-up space. The cliche of wearing many hats fits as Kevin has brokered agreements and negotiated contracts, headed product lines and managed their associated teams, overseen the creation of website and technology platforms, trafficked advertising campaigns, created design briefs, implemented SEO strategies, and developed countless deep customer relationships. He is passionate about applying the lessons learned along the way to help this outstanding pharmacovigilance team build their operations to help your team accomplish its goals. Prior to joining PPV, Kevin was the Director of Product Management at the real estate technology company Booj, the founder of Pour, and the Director of Business Development at the video technology company blinkx. Kevin obtained his Bachelor of Science in Business Administration as well as a minor in Philosophy from Bucknell University.
For the last 12 years, Paula has been a stay-at-home mom. Prior to that she worked for 10 years as an Executive Assistant to a named partner at a well-known entertainment law firm. At that time, some of the lawyers decided to start their own entertainment law firm. Paula was asked to work for one of the lawyers and help with the launch of the new firm. She worked there for 3 years. Paula is based remotely in Valley Village, CA with her husband Chris, son Joshua, and their two dogs, Sydney and Sophie. Paula also has two older daughters, Madison and Morgan. Her hobbies include working out, going on hikes and enjoying time with her family.
Serena Baylis has been helping companies reach their true potential for over 10 years. Leveraging excellent organizational alongside leadership and teamwork skills, Serena manages crucial business operations allowing PPV to blossom and flourish. She began her career in marketing and moved into an operational role where she managed a full spectrum of projects including overseeing recruitment, managing office support staff, facilitating office build outs in addition to partner implementation and support. Prior to her role with PPV, Serena oversaw US and UK operations at Darktrace and prior to that, blinkx.