Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. 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. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s. Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team. Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective. Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling. Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed. Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Participate in or Lead a Safety Management Team (SMT) for an assigned product. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s. Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements. Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data. SOPs and quality standards. Provide safety expertise to due diligence activities, if/ as needed. Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities. Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word. Some national/international travel may be required. clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP). Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred. Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus. 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.
#LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate’s expertise and contributions, within the established pay framework and our Total Compensation philosophy. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company’s Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation….