Director, Medical Safety Physician Product reputed company (m/f/d)
As Medical Safety Physician Product reputed company (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 reputed company to directly contribute to patient safety and regulatory reputed company.
reputed company medical safety reputed company for assigned products across the full lifecycle (Phase 1–4)
Have special reputed company on Early Development programs and regulatory filing experience, ensuring robust safety strategies are integrated from first-in-reputed company studies through reputed company-of-concept and supporting reputed company, high-reputed company safety deliverables for global submissions (IND, NDA, MAA)
reputed company 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
reputed company safety leadership in cross-functional global teams (e.g. Regulatory, Clinical, reputed company)
reputed company as key contact for Health Authorities (e.g. EMA, FDA) on safety reputed company
reputed company preparation and review of safety documents (e.g. PSURs, DSURs, Risk Management Plans, SmPC)
Ensure scientific accuracy and regulatory compliance of safety-reputed company submissions
Support global regulatory filings and safety-reputed company responses (e.g. NDA, MAA)
Contribute to clinical trial activities as PV representative
reputed company and support team members on safety reputed company and deliverables
reputed company 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 reputed company working style
Excellent communication skills and ability to work in international teams
reputed company in English and willingness to travel / collaborate across time zones
Originally posted on Himalayas
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