Global Drug Safety & Pharmacovigilance Physician
Live Well Homecare · Bayonne, NJ · 1 wk ago
HealthcareFull-time
The GDS & PV Physician is a senior medical role responsible for overseeing the safety strategy and profile of assigned products throughout their lifecycle. As an individual contributor at the Director level , you will collaborate cross-functionally and with external stakeholders, including regulatory authorities, to assess safety data, review adverse events, and prepare safety reports. Key duties include leading safety activities such as signal detection, benefit-risk evaluation, and risk management, as well as managing safety issues and implementing mitigation strategies. You will provide guidance, training, and mentorship on pharmacovigilance principles, foster internal and external safety communications, and support regulatory submissions and inspections. Qualifications include a medical degree ( MD ), minimum of 12+ years in drug safety/pharmacovigilance, experience with regulatory processes (including BLA/NDA submissions), and familiarity with safety databases, coding dictionaries, and global PV regulations. Essential skills involve strong scientific acumen, stakeholder engagement, adaptability, and leadership in safety monitoring. Join a collaborative, innovative environment dedicated to advancing impactful therapies for serious diseases.