What are the responsibilities and job description for the Global Drug Safety & Pharmacovigilance Physician position at LiveWell Homecare Agency?
Role Overview: The GDS & PV Physician is a senior safety expert responsible for contributing to the global safety strategy and safety profile of assigned products throughout their lifecycle.
Key Responsibilities: Lead safety activities including signal detection, benefit-risk evaluation, and risk management; collaborate with cross-functional teams on safety assessments, literature reviews, and safety reports; oversee safety issue handling and risk mitigation; prepare regulatory documentation; manage internal and external safety forums; provide guidance, training, and mentorship on pharmacovigilance (PV) principles; and engage with regulatory authorities and external stakeholders.
Qualifications & Skills: Medical degree (MD) with at least 12 years of experience in drug safety/pharmacovigilance, preferably in oncology; expertise in BLA/NDA submissions, PV audits, and regulatory inspections; familiarity with global PV regulations, coding dictionaries (MedDRA, WHODrug), and safety databases (e.g., ARISg, ARGUS); proven leadership in guiding and mentoring teams; strong communication and collaboration skills; ability to adapt in a fast-paced environment.
This role is pivotal in ensuring product safety, regulatory compliance, and advancing innovative therapies to improve patient outcomes.