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

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 Requirements - 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 Originally posted on Himalayas