Alyssa Lenzinger 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.

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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.

Danieli Neder is a pharmacist by training with more than 17 years of experience in clinical research industry, 15 of them dedicated to Pharmacovigilance, Drug Safety and Risk Management activities, working for 14 years for a large global contract research organization (CRO). Focused on Safety Sciences and Risk Management activities, Danieli has extensive experience in aggregate safety data review, safety surveillance, signal management and signal detection activities, authoring and coordination of aggregate safety reports, literature search and review, support development and maintenance of product reference safety information (RSI), processes development and implementation. Danieli’s experience also includes pharmacovigilance operations, like oversight of PV activities for global phase II and III studies, authoring Safety Management Plans, Individual Case Safety Report management, safety data entry, narrative writing, and submissions to regulatory agencies.  Therapeutic area experience includes oncology, hematology, neurology, gastroenterology, and gene therapy. Danieli is natively fluent in Portuguese and fluent in English. She is based in Campinas, Sao Paulo State, Brazil.

David Blackett 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.

Diane Dahill is an active registered pharmacist in Massachusetts and Florida for the past 40+ years.  Her clinical pharmacy experience included working in acute and sub-acute care as well as decades of working in major medical centers (Mass General Hospital (Boston), Dana Farber/Jimmy Fund (Boston), John’s Hopkins (All Children’s hospital) (St Petersburg FL). Clinical focus included working in general medicine, oncology, clinical trials and pediatric disease.  JCAHO accreditation specialist in both nursing homes and medical center settings.  Diane entered the biotech/pharma field in 2002 starting in an international top CRO before transitioning to the Sponsor side.  Her work history includes 22+ years in 2 major CROs and multiple small, medium and large pharma/biotech companies.  Pharma /biotech career focus includes drug safety pharmacovigilance (phase I – IV and post marketing) specializing in oncology (CAR T, radioimmunotherapy, small molecule), infectious disease and rare disease in adult and pediatric population.  PV department creation/development experience includes 12+ years with focus on PV strategy, PVA partnership agreements, PV science, ISTs, PV operations development and NDA preparation.  Diane holds a BS in pharmacy from the Massachusetts College of Pharmacy (Boston), MS in toxicology from Northeastern University (Boston) and a Pharm D from Howard University (Washington DC).  She has certifications in herbal therapy, emergency contraception, NxStage home hemodialysis, immunization, diabetes and pharmacogenomics.

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.

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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.

Maria Schissel has 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.

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Susan Kindig, MD, JD started her career in pharmacovigilance as a medical safety physician at Eli Lilly, honing her safety skills in a wide variety of therapeutic areas (pain, neurodegeneration, CV, men’s health, osteoporosis, psychiatry, infectious disease) and spanning the drug development process from before man to post-marketing.  For several years as an individual contributor, she developed expertise in all routine regulatory documents, signal detection and management, label management and negotiation, global regulatory queries and benefit/risk evaluations.  She grew to particularly enjoy the due diligence and sought out every opportunity to participate in Lilly’s robust process.  Susan’s strengths in leadership and mentoring helped her to move into a leadership role at Lilly, managing a global team that covered comprehensive Medical Safety for a quarter of Lilly’s portfolio.  She helped lead her team to successful removal of a black box warning from a label, release from a pregnancy registry using post-marketing data, as well as numerous regulatory submissions and approvals across the regions.  She later served as the head of safety for Halozyme where she helped guide the Safety team through an integration of a subsidiary safety organization (consolidation to single call center, bringing safety surveillance and case management activities for subsidiary in-house, etc.) within the parent organization while gaining valuable experience in medical device safety.

Prior to her work in pharmacovigilance, Susan was a board-certified OB/GYN in the Indianapolis area for 12 years post-residency, serving as the Chief of OB/GYN prior to leaving clinical medicine.  Mid-career, Susan took a detour from Medicine to pursue a life-long interest in law school, which helped to strengthen her writing skills for later use in her pharma career.  She has maintained an interest throughout her career in genetics which she had studied both as an undergraduate and later for a year in graduate school prior to attending medical school.

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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 Carvalheiro 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 Tan 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.

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