Global Drug Safety & Pharmacovigilance Physician

Role Overview The Drug Safety & Pharmacovigilance (GDS&PV) Physician is a senior medical expert responsible for overseeing the safety profile of assigned products throughout their lifecycle. Key Responsibilities Lead pre- and post-marketing safety activities, including signal detection, benefit-risk assessment, and risk management.Collaborate cross-functionally to review adverse events, scientific literature, and safety reports, ensuring accurate safety assessment and communication.Manage safety issues, implement risk mitigation strategies, and contribute to regulatory documentation such as safety summaries and aggregate reports.Engage with external stakeholders like regulatory authorities and Data Monitoring Committees, representing the safety department.Provide safety guidance, training, and mentorship to internal teams and external partners, fostering safety awareness and compliance. Qualifications & Skills Medical degree (MD) with 12+ years of experience in drug safety/pharmacovigilance, ideally in oncology.Experience with regulatory submissions (BLA/NDA), audits, and working with agencies like the FDA.Proficiency in global PV regulations, coding dictionaries (MedDRA, WHODrug), and safety databases (e.g., ARISg, ARGUS).Strong leadership skills with experience mentoring team members and working effectively in a dynamic environment.