Associate Safety Director

Associate Safety Director (m/f/d) General Information

• Location:
  
  Basel
• Start: 21.08.2026
• Duration: 12 months (Extension possible)
• Home Office:
  First 3 months full on-site presence for training; afterwards, max. 40%

• 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).
• Review key clinical documents (protocols, study reports, IB, ICF) to ensure alignment with the safety strategy and appropriate risk communication.
• Provide safety-science input to regulatory submissions and governance/oversight forums (e.g., IND/NDA/MAA activities, iDMC/IMC, DSC/DRC), collaborating with SSLs, teams, and vendors.

• Qualified healthcare professional or Life Sciences graduate (postgraduate degree such as PhD/MSc/PharmD is an advantage).
• More than 4 years drug development experience (pharma or related industry).
• More than 3 years in drug safety/pharmacovigilance (or closely related field).
• Strong Excel/Word/PowerPoint skills; able to extract data from safety databases and apply complex data analysis.
• Fluent English (written and spoken)

Interested? Then apply today. We look forward to hearing from you!