Director, Medical Safety Physician Product Lead (m/f/d)
otsukapharmagmbh
Homeoffice · Frankfurt am Main · Deutschland
Posted Jun 17, 2026
- Full-time
- Remote
- Global Pharmacovigilance
- experienced
otsukapharmagmbh
Homeoffice · Frankfurt am Main · Deutschland
Posted Jun 17, 2026
As Medical Safety Physician Product Lead (Director), you will play a key role in ensuring the safety of our products across their entire lifecycle. 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. Regulatory, Clinical, Quality)
Act as key contact for Health Authorities (e.g. 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. 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
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