Associate Safety Director – Pharmaceutical (Basel)

About the role

We are seeking an Associate Safety Director to join a leading pharmaceutical company in Basel. The professional will be responsible for the safety strategy of assigned products, overseeing case reporting, signal detection and risk management throughout the drug development lifecycle.

Key responsibilities

• Develop and maintain an expert understanding of the safety profile of assigned products and their therapeutic context.
• Manage individual and aggregate case reporting, including ICSR medical review and preparation of DSUR and PBRER reports.
• Lead signal detection, assessment and risk management activities, including CCDS and RMP maintenance.
• Review clinical protocols, study reports, Investigator’s Brochures, informed consent forms and ensure alignment with safety strategy.
• Prepare safety sections for regulatory submissions (IND, NDA, MAA, variations, renewals).
• Support Drug Monitoring Committees, Drug Safety Committee and Development Review Committee with safety presentations.
• Act as functional business process owner or subject‑matter expert for specialized safety projects.

Required profile

• Minimum 4 years of experience in drug development or pharmacovigilance.
• Strong knowledge of global safety regulations and reporting requirements.
• Ability to work independently and collaborate with cross‑functional teams.
• Fluent in English; German or French is a plus.

Required skills

• ICSR case management
• DSUR and PBRER preparation
• Signal detection and assessment
• Risk management (CCDS, RMP, labeling)
• Regulatory submission preparation (IND, NDA, MAA, variations)
• Clinical protocol and Investigator’s Brochure review

What we offer

• One‑year fixed‑term contract with a leading pharma organization.
• Hybrid work mode – onsite in Basel with remote option after onboarding.
• Opportunity to influence safety strategy for innovative therapies.