Associate Safety Director

Associate Safety Director (m/f/d)

General Information

• Location: Basel
• Start:
• Duration: 12 months (Extension possible)
• Home Office: First 3 months full on-site presence for training; afterwards, max. 40%

Your Responsibilities

• Own and maintain an expert understanding of the safety profile of assigned product(s)/therapy area(s) and their strategic context (disease, MoA, competitors).
• Lead case management and reporting activities: medical review of ICSRs and aggregate reports (e.g., DSUR, PBRER).
• Drive signal detection and signal management, including safety assessments and responses to Health Authority requests (incl. quality-related safety topics).
• Contribute to and help shape the product safety strategy, including benefit–risk considerations.
• Independently manage risk management deliverables (e.g., RMP, CCDS, labeling/IB updates and risk communications)...