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 activitiesDrive and chair Safety Management Team (SMT) meetingsEnsure execution of global pharmacovigilance (PV) activities and governance processesProvide 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 mattersLead preparation and review of safety documents (e.g.

PSURs, DSURs, Risk Management Plans, SmPC)

Ensure scientific accuracy and regulatory compliance of safety-related submissionsSupport global regulatory filings and safety-related responses (e.g.

NDA, MAA)

Contribute to clinical trial activities as PV representativeCoach and support team members on safety strategy and deliverablesAct as subject matter expert for audits, inspections, and process improvements

Requirements

Medical Doctor with clinical experienceMultiple years of experience in pharmacovigilance / medical safetyStrong knowledge of global PV regulations (EU GVP, FDA

Requirements

)Experience with global development programs and regulatory submissionsSolid understanding of benefit-risk evaluation and safety scienceStrong analytical thinking and structured working styleExcellent communication skills and ability to work in international teamsFluency in English and willingness to travel / collaborate across time zonesOriginally posted on Himalayas