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 their lifecycle. This includes generating all major pre- and post‑marketing safety deliverables including signal, benefit‑risk evaluation and risk management activities. The role requires effective cross‑functional collaboration with regulatory authorities and internal stakeholders.
Responsibilities
* Provide Medical Safety/PV inputs for assigned products, including clinical development phases, investigator‑sponsored, compassionate use, and disease monitoring programs.
* Support global launch activities for assigned products through safety perspective.
* Prepare and review safety sections of clinical, regulatory, and scientific documents (protocols, CRFs, IRB/EC requests, regulatory submissions, briefing books, manuscripts, etc.).
* Collaborate in creation and maintenance of Company Core Safety Information (CCSI) and ensure its implementation in labeling and reference safety information.
* Conduct literature reviews and signal detection activities; analyze individual and aggregate data; document and communicate safety signals and trends.
* Chair the Safety Management Team (SMT) for products under authority and participate in executive forums.
* Oversee preparation and review of pre‑ and post‑marketing aggregate safety reports (PSURs, PBRERs, PADERs, DSURs, IND annual reports, SUSAR line listings).
* Contribute to Risk Management Plans (RMPs) for assigned products, identifying risks and minimization strategies.
* Provide guidance on adverse event (MedDRA) and drug (WHODrug) coding.
* Ensure compliance with global PV regulations (CIOMS, EMA, FDA, ICH, etc.) and participate in inspection readiness activities.
* Represent PV in cross‑functional forums and committees involving products under responsibility.
* Maintain key performance indicators to achieve PV excellence.
* Stay current on PV regulations, guidance, and industry best practices.
Qualifications
* MD required (or equivalent); medical licensure in at least one state preferred.
* Clinical research and/or fellowship training in internal medicine, neuroscience, hematology/oncology, or other relevant specialty is a plus.
* Minimum 3 years of Drug Safety/Pharmacovigilance experience, or 3+ years of clinical development experience.
* MedDRA‑trained with working knowledge of MedDRA and WHO Drug coding dictionaries.
* Experience with PV audit process and participation in regulatory authority inspections preferred.
* Strong written and oral communication, organizational, and cross‑functional teamwork skills.
* Proficiency in external regulatory databases, Microsoft Excel, PowerPoint, and Word.
* High level of initiative, independence, and ability to manage multiple tasks with deadlines.
* Willingness to travel nationally/internationally as required.
Education & Licenses
* MD required (or equivalent); medical licensure in at least one state preferred.
* Clinical research/fellowship training in internal medicine, neuroscience, hematology/oncology, or other relevant specialty is a plus.
Benefits & Compensation
Base pay range: $212,000.00 – $318,000.00. The successful candidate may also be eligible for discretionary annual cash bonus or incentive compensation, discretionary equity grants, and a full benefits package including medical, dental, vision insurance, 401(k) retirement savings plan, and flexible paid vacation.
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