Medical Director, Medical Safety

Brief Description The Global Safety Physician is 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 the 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 summaries of safety, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts/journal articles). Serve as the safety representative for Global Regulatory and Core Development teams. Interface with the REMS team to optimize risk management of assigned products from a PV perspective. Support creation/maintenance of Company Core Safety Information (CCSI) and ensure CCSI implementation in Reference Safety Information (RSI) including Investigator Brochures, CCDS, national labels, and related product labeling. Review medical/scientific literature to support signal detection and aggregate reporting. Support signal detection activities: identification, evaluation, validation; individual and aggregate data analyses; interpret safety signals/trends; document and communicate safety assessments (written and verbal) with CRSO and PV management. Participate in or lead a Safety Management Team (SMT) for assigned products. Contribute to pre- and post‑marketing aggregate safety reports (IND Annual Reports; 6‑monthly SUSARs line listings) and ensure consistent safety communications across regulatory documents. Contribute to Risk Management Plans (RMPs) including risk identification and appropriate risk minimization/effectiveness measures. Provide guidance on MedDRA and WHO Drug coding for clinical and postmarketing safety data. Stay current on global PV/safety regulations and guidance; provide safety expertise to due diligence activities as needed. Minimum Requirements 2–5 years of experience in Clinical Development, Medical Affairs, or Drug Safety/Pharmacovigilance (other relevant medical affairs experience may be considered). Excellent knowledge of the drug development process. Initiative and independence; excellent written/oral communication; resourcefulness and organization; demonstrated cross‑functional teamwork. Computer literacy: external Regulatory Databases; Microsoft Excel, PowerPoint, and Word. Some national/international travel may be required. Leadership / Additional Qualifications (Preferred) Working knowledge of international regulations and Good Clinical and Pharmacovigilance practices (GCP, GVP). Exposure to working relationship with FDA/EMA and other regulatory authorities preferred. Working knowledge of safety databases (e.g., ARISg, ARGUS) and electronic data capture systems a plus. MedDRA training and working knowledge of MedDRA/WHO Drug coding dictionaries a plus. Education and Licenses MD required; medical licensure in at least one region preferred. Clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus. Benefits (US, explicitly mentioned) Medical, dental and vision insurance; 401k retirement savings plan; flexible paid vacation. #J-18808-Ljbffr