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  • Otsuka Pharma GmbH

    Frankfurt am Main

    • 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


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