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 safety and risk/benefit evalu...