Director, Medical Safety Physician Product Lead (m/f/d)

Das ist der Job

Regulatory, Clinical, Quality) • Act as key contact for Health Authorities (e.g.

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Darum lohnt es sich

You will combine medical expertise with strategic leadership to drive global pharmacovigilance activities, collaborate with cross-functional teams, and shape robust safety and risk management strategies.

This position offers broad exposure to international stakeholders and the opportunity to directly contribute to patient safety and regulatory excellence. • Lead medical safety strategy for assigned products across the full lifecycle (Phase 1–4) • Have special focus on Early Development programs and regulatory filing experience, ensuring robust safety strategies are integrated from first-in-human studies through proof-of-concept and supporting timely, high-quality safety deliverables for global submissions (IND, NDA, MAA) • Oversee safety profile, benefit-risk evaluation, and signal detection activities • Drive and chair Safety Management Team (SMT) meetings • Ensure execution of global pharmacovigilance (PV) activities and governance processes • Provide safety leadership in cross-functional global teams (e.g.

NDA, MAA) • Contribute to clinical trial activities as PV representative • Coach and support team members on safety strategy and deliverables • Act as subject matter expert for audits, inspections, and process improvements Stellenanforderungen • 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 • Solid understanding of benefit-risk evaluation and safety science • 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 Alles erledigt!

Jobbeschreibung As Medical Safety Physician Product Lead (Director), you will play a key role in ensuring the safety of our products across their entire lifecycle. EMA, FDA) on safety matters • Lead preparation and review of safety documents (e.g.

PSURs, DSURs, Risk Management Plans, SmPC) • Ensure scientific accuracy and regulatory compliance of safety-related submissions • Support global regulatory filings and safety-related responses (e.g. Ihre Bewerbung wurde eingesendet! Leider haben Sie sich bereits auf diese Stelle beworben.