Risk management & mitigation activities

• Risk Management strategy development, RMM implementation, REMS support, tracking strategies, and effectiveness monitoring
• Benefit risk assessment

Signal detection

• Accurate source selection, including literature and social media
• Developing a risk-based process to confirm or refute signals, including tracking
• Signal escalation and communication processes

Key safety governance contributions

• Develop safety governance
• Establish signal detection and signal management process
• Create and oversee labeling management process
• Develop and maintain DCSI, CCSI, and RSI