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arbeitnow

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

Company: Otsuka Pharma GmbH
Location: Homeoffice (Remote)
Posted: 8/6/2026
Source: arbeitnow
Job ID: remote-director-medical-safety-physician-product-lead-frankfurt-am-main-483546

<p class="MsoNormal" style="text-align:justify;">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.</p><p class="MsoNormal" style="min-height: 1.7em;"></p><ul><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Lead medical safety strategy for assigned products across the full lifecycle (Phase 1–4)</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;">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)</p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Oversee safety profile, benefit-risk evaluation, and signal detection activities</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Drive and chair Safety Management Team (SMT) meetings</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Ensure execution of global pharmacovigilance (PV) activities and governance processes</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Provide safety leadership in cross-functional global teams (e.g. Regulatory, Clinical, Quality)</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Act as key contact for Health Authorities (e.g. EMA, FDA) on safety matters</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Lead preparation and review of safety documents (e.g. PSURs, DSURs, Risk Management Plans, SmPC)</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Ensure scientific accuracy and regulatory compliance of safety-related submissions</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:jus...

Global PharmacovigilanceRemote

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