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 (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 (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 (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).
Minimum candidate level required: Associate Safety Director.
Strong Excel/Word/PowerPoint skills; able to extract data from safety databases and apply complex data analysis.
Fluent English (written and spoken).

Location: Basel
Workload: 100%
Duration: 12 months (Extension possible)
Home Office: First 3 months full on-site presence for training; afterwards, max. 40%
Interested? Then apply today. We look forward to hearing from you!

Associate Safety Director (m/f/d)

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