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Associate Safety Director
Flexsis · Bâle
Description du poste
About the role
We are looking for an experienced Associate Safety Director to join our global pharmaceutical development environment. The role provides end‑to‑end safety science and pharmacovigilance support for early‑phase, late‑phase, and marketed products, ensuring patient safety through strategic risk management and regulatory compliance.
Key responsibilities
- Develop and maintain an expert understanding of the safety profile of assigned products and therapeutic areas.
- Manage individual case safety reports (ICSR) and aggregate reporting such as DSUR and PBRER.
- Lead signal detection, evaluation, and risk management activities, including CCDS and RMP maintenance.
- Contribute to safety strategy, risk communications, and preparation of regulatory submissions (IND, NDA, MAA, variations, renewals).
- Review clinical protocols, study reports, Investigator’s Brochures, informed consent forms, and other documents for safety alignment.
- Prepare and maintain core safety documents, including labeling and safety sections of regulatory dossiers.
Required profile
- Strong background in drug development and pharmacovigilance.
- Ability to work independently and apply expert judgment in complex safety evaluations.
- Excellent communication and analytical skills, with the capacity to present complex safety data clearly.
- Experience collaborating with cross‑functional global teams and safety leadership.
Required skills
What we offer
- 12‑month contract with full‑time workload.
- Initial three‑month on‑site training followed by a hybrid working model.
- Opportunity to work in a leading global pharmaceutical environment in Basel.
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Flexsis
Bâle
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