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

<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:justify;"><span style="color:#3F3F3F">Support global regulatory filings and safety-related responses (e.g. NDA, MAA)</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Contribute to clinical trial activities as PV representative</span></p></li><li><p class="MsoListParagraphCxSpMiddle" style="text-align:justify;"><span style="color:#3F3F3F">Coach and support team members on safety strategy and deliverables</span></p></li><li><p class="MsoListParagraphCxSpLast" style="text-align:justify;"><span style="color:#3F3F3F">Act as subject matter expert for audits, inspections, and process improvements</span></p></li></ul> <br> <ul><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Medical Doctor with clinical experience</span></p></li><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Multiple years of experience in pharmacovigilance / medical safety</span></p></li><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Strong knowledge of global PV regulations (EU GVP, FDA requirements)</span></p></li><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Experience with global development programs and regulatory submissions</span></p></li><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Solid understanding of benefit-risk evaluation and safety science</span></p></li><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Strong analytical thinking and structured working style</span></p></li><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Excellent communication skills and ability to work in international teams</span></p></li><li><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="color:#3F3F3F">Fluency in English and willingness to travel / collaborate across time zones</span></p><p><span style="color:#3F3F3F"><br></span></p></li></ul><p>Find <a href="https://www.arbeitnow.com">Jobs in Germany</a> on Arbeitnow</a>