Director, Medical Safety Physician Product Lead (m/f/d)
Remote · Frankfurt am Main, Hesse, Germany or Germany
Job Summary
Lead medical safety strategy for products across the full lifecycle (Phase 1–4) with focus on Early Development and regulatory filing experience; oversee safety profile, signal detection, and risk management; chair Safety Management Team (SMT) meetings; ensure global PV activities and governance; provide safety leadership in cross-functional teams; act as key contact for Health Authorities (EMA, FDA); lead safety document preparation (PSURs, DSURs, Risk Management Plans, SmPC) and support regulatory filings; coach team members on safety strategy and deliverables and act as SME for audits/inspections; requires Medical Doctor qualification, extensive pharmacovigilance experience, and ability to travel.
Required Qualifications
- Medical Doctor with clinical experience
- Multiple years of experience in pharmacovigilance / medical safety
- Strong knowledge of global PV regulations (EU GVP, FDA requirements)
- Experience with global development programs and regulatory submissions
- Strong analytical thinking and structured working style
- Excellent communication skills and ability to work in international teams
- Fluency in English and willingness to travel / collaborate across time zones
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.