Brief Description The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. Responsibilities Lead preparation and review of safety-related sections for assigned product/s (e.g., protocols, informed consent/assent, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts/journal articles). Serve as safety representative on a Global Regulatory Team and Core Development Team. Interface with the REMS team to optimize risk management from a PV perspective. Support creation/maintenance of Company Core Safety Information (CCSI) and ensure implementation in Reference Safety Information (RSI) (e.g., Investigator Brochures, CCDS, national labels, and associated product labeling). Review medical/scientific literature to support signal detection and aggregate reporting. Support signal detection/assessment: identification, evaluation, validation; conduct individual and aggregate analyses; interpret safety signals/trends; document and communicate safety assessments with CRSO and PV management. Participate in or lead Safety Management Teams (SMT) for assigned products. Contribute to pre- and post-marketing aggregate safety reporting (IND Annual Reports, 6-monthly SUSAR line listings) and consistent communication across regulatory safety documents. Contribute to Risk Management Plans (RMPs) (risk identification, risk minimization, and effectiveness measures). Provide guidance on adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data. Demonstrate knowledge of global PV regulations/guidelines, SOPs, and quality standards; keep abreast of PV/safety updates. Provide safety expertise to due diligence activities (if/as needed). Minimum Requirements 2–5 years of Clinical Development, Medical Affairs, or Drug Safety/Pharmacovigilance experience (other relevant medical affairs may be considered). Required Skills/Abilities Excellent knowledge of the drug development process. High initiative and independence. Excellent written and oral communication; resourcefulness and personal organization; demonstrated cross-functional teamwork. Computer literacy including proficiency with external regulatory databases and Microsoft Excel, PowerPoint, and Word. Ability to manage multiple tasks with deadlines in a fast-paced environment. Some national/international travel may be required. Preferred Skills Working knowledge of safety databases (e.g., ARISg, ARGUS) and electronic data capture systems. MedDRA training and working knowledge of MedDRA and WHO Drug coding dictionaries. Exposure/working relationship with FDA, EMA, and other regulatory authorities. Education/Licenses MD required; medical licensure in at least one region preferred. Benefits (US) Eligible for medical, dental, and vision insurance; 401(k) retirement savings plan; and flexible paid vacation. #J-18808-Ljbffr