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

Otsuka Pharma GmbH

HomeofficeRemote

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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 Find more English Speaking Jobs in Germany on Arbeitnow Tags: Global Pharmacovigilance, Remote

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