1 Essential Functions/Responsibilities

The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle. This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, 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. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

• Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator

Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence

• Provide Medical safety/PV inputs to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products
• Participate in the preparation and review of safety-related section(s) for 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 products
• Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and with the Jazz Labeling Committee 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
• Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed
• Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products 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 key internal/external stakeholders
• Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums for assigned products
• Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products
• 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 (WHODrug) coding for clinical and post-marketing safety data
• Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections
• Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company’s goals
• Contribute to key performance indicators to ensure PV excellence
• Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned
• Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities

2 Required Knowledge, Skills, and Abilities

• 
  Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas and European Union, territories including an understanding of case processing procedures and other pharmacovigilance processes
• Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems
• MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries
• Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred
• Ability to manage multiple tasks with deadlines in fast-paced working environment
• Knowledge of drug development process
• Requires a high level of initiative and independence
• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
• Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word
• Some national/international travel may be required

3 Required/Preferred Education and Licenses

• MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus
• Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered

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