Associate Safety Director

About the role

We are seeking an Associate Safety Director to join a leading pharmaceutical company in Basel. The role focuses on the safety profile of assigned products, ensuring robust risk management and regulatory compliance throughout the product lifecycle.

Key responsibilities

• Maintain expert knowledge of product safety, disease context, mechanism of action and competitive landscape.
• Lead case management and reporting, including medical review of individual case safety reports (ICSRs) and aggregate reports such as DSUR and PBRER.
• Drive signal detection, safety assessments and respond to health authority inquiries, including quality‑related safety topics.
• Shape product safety strategy, manage risk‑management deliverables (RMP, CCDS, labeling updates, risk communications).
• Review clinical documents (protocols, study reports, IB, ICF) to align with safety strategy and risk communication.
• Provide safety‑science input for regulatory submissions and governance forums, collaborating with cross‑functional teams and external vendors.

Required profile

• Qualified healthcare professional or Life Sciences graduate; postgraduate degree (PhD, MSc, PharmD) is a plus.
• Minimum 4 years of drug development experience and at least 3 years in drug safety/pharmacovigilance.
• Fluent written and spoken English.

Required skills

• Advanced proficiency in Microsoft Excel.
• Strong skills in Microsoft Word.
• Competent use of Microsoft PowerPoint for data presentation.