Develop and maintain expert knowledge of product safety profiles, disease contexts, competitor safety data, and mechanisms of action
Lead medical reviews for individual case safety reports (ICSR) and aggregate reporting (DSUR, PBRER), including responses to regulatory inquiries
Drive signal detection, assessment, and management, including strategy development for safety evaluations and drug safety reports
Independently own risk management activities: develop and maintain Company Core Data Sheet, labeling documents, risk communications, and Risk Management Plans
Review clinical trial materials (protocols, study reports, Investigator’s Brochure, ICF) to ensure alignment with safety strategies and risk management approaches
Contribute safety science expertise to regulatory submissions
Participate in and provide input to Drug Monitoring Committees (iDMC) and internal monitoring co...
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