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 their lifecycle.
- Generate all major pre‑ and post‑marketing safety deliverables, including signal detection, benefit‑risk evaluation, and risk‑management activities.
- Interface cross‑functionally at all organizational levels and with external regulatory authorities.
- Work under the supervision of the Senior Medical Director to manage the safety assessment of products, review aggregate safety analyses and scientific literature, prepare safety reports, and communicate changes in product risk profiles to internal and external stakeholders.
- Operate effectively in a dynamic, changing environment to meet corporate and patient needs.
- Provide Medical Safety/Pharmacovigilance (PV) inputs to assigned products, including clinical development programs of all phases, investigator‑sponsored studies, compassionate use, and disease‑monitoring programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations, Data Monitoring Committees, and other entities to contribute to study execution while ensuring safety strategy and operational excellence.
- Support the Jazz Pharmaceuticals Commercial organization in global launch activities for assigned products.
- Participate in the preparation and review of safety‑related sections for clinical, regulatory, and scientific documents—protocols, informed consent/assent forms, case report forms, statistical plans, clinical study reports/synopses, integrated safety summaries, NDAs/BLA, MAA, CTD submissions, regulatory agency responses, IRB/EC requests, briefing books, manuscripts, journal articles, and other documents; ensure the safety profile is 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—including Investigator Brochures, Company Core Data Sheets, national labels, and other product labeling.
- Review medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products.
- Conduct signal detection activities to ensure signal identification, evaluation, validation; interpret safety signals and trends; document and communicate safety assessments (written and verbal) of safety risks with key internal and external stakeholders.
- Chair the Safety Management Team (SMT) for products under authority and participate in other executive forums for assigned products.
- Serve as signatory and overseer of the preparation and review of pre‑ and post‑marketing aggregate safety reports—including PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, and 6‑month SUSAR line‑listing reports; ensure consistent communication of safety profile and topics across regulatory safety documents for assigned products.
- Contribute to the preparation of Risk Management Plans (RMPs) for assigned products, ensuring identification of risks and appropriate risk‑minimization and effectiveness measures in accordance with regulatory requirements.
- Provide guidance on adverse event (MedDRA) and drug (WHO‑Drug) coding for clinical and post‑marketing safety data.
- Demonstrate knowledge of and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; actively participate 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.
- Keep abreast of new PV/safety regulations and guidance from regulatory authorities.
Knowledge, Skills, and Abilities
- Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards, and Good Pharmacovigilance Practices (GVP) in the Americas and European Union territories, including an understanding of case processing procedures and other pharmacovigilance processes.
- Working knowledge of safety databases (e.g., ARISg, ARGUS) and electronic data capture systems.
- MedDRA‑trained and working knowledge of MedDRA and WHO Drug coding dictionaries.
- Experience with PV audit processes and active participation in regulatory authority inspections.
- Ability to manage multiple tasks with deadlines in a fast‑paced working environment.
- Knowledge of drug development process.
- High level of initiative and independence.
- Excellent written and oral communication skills, resourcefulness, personal organization, and demonstrated cross‑functional teamwork.
- Computer literacy with proficiency in external regulatory databases, Microsoft Excel, PowerPoint, and Word.
- Availability for some national/international travel as required.
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 of clinical development experience.
Compensation & Benefits
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and strives to provide employees with a market‑competitive total compensation package. The full base pay range for this role is $212,000.00 – $318,000.00. Compensation within this range depends on qualifications, skills, experience, and job knowledge. The role may also be eligible for discretionary annual cash bonus or incentive compensation and equity grants under the company’s long‑term incentive plan. Eligible employees may participate in medical, dental, and vision insurance, a 401(k) retirement savings plan, and a flexible paid vacation program. For more information on our benefits offerings, see https://careers.jazzpharma.com/benefits.html.
Equal Opportunity
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 other characteristic protected by law.
