Associate Medical Director, Global Drug Safety

Key Responsibilities

• Through data review and research, identifies and presents safety issues for further review and analysis at Safety Management Team meetings
• Assists in preparation of safety data for DSMBs and other safety governance meetings
• Represents GDS on other project or product teams as a key cross‑functional member and subject‑matter expert
• Detects, validates and manages pre‑ and/or post‑approval safety signals through to resolution
• Conducts medical review of Individual Case Safety Reports (ICSRs) and analysis of similar events (AOSE) as necessary, including assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes in process
• Evaluates aggregate safety data and contributes to core regulatory documents such as Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non‑routine s...