Director, Safety Physician - Medical Safety (Remote)
Apply for the Director, Safety Physician - Medical Safety (Remote) role at Jazz Pharmaceuticals.
Jazz Pharmaceuticals is a global biopharma company dedicated to developing life‑changing medicines for serious diseases. The company focuses on sleep disorders, epilepsy, oncology, and neuroscience therapies. Headquartered in Dublin, Ireland, Jazz has R&D laboratories, manufacturing facilities, and employees worldwide.
Brief Description
The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product(s) throughout their lifecycle. This includes supporting major pre‑ and post‑marketing safety deliverables including signal detection, benefit–risk evaluation and risk management activities.
Essential Functions
* Lead the preparation and review of safety‑related sections for product(s). Documents include protocols, informed/assent forms, case report forms, statistical plans, clinical study reports, integrated safety summaries, New Drug or Biologic License Applications, Marketing Authorization Applications, Common Technical Document submissions, regulatory responses, briefing books, manuscripts and other related documents, ensuring the safety profile is accurately reflected.
* Serve as the safety representative on a Global Regulatory Team and a Core Development Team.
* Interface with the Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective.
* Support creation and maintenance of Company Core Safety Information (CCSI) and ensure its implementation in all Reference Safety Information including Investigator Brochures, Company Core Data Sheets, national labels, and associated product labeling.
* Review medical/scientific literature to identify relevant content for signal detection activities and aggregate reporting.
* Support signal detection activities: identify, evaluate, validate signals, interpret safety trends, and document and communicate safety assessments in collaboration with the CRSO and PV management.
* Participate in or lead a Safety Management Team (SMT) for an assigned product.
* Prepare pre‑ and post‑marketing aggregate safety reports, including IND Annual Reports, 6‑monthly SUSAR Line Listing Reports, and ensure consistent communication of safety profile across regulatory documents.
* Contribute to preparation of Risk Management Plans (RMPs) for assigned products, ensuring identification of risks and corresponding mitigation measures in line with regulatory requirements.
* Provide guidance on adverse event (MedDRA) and drug (WHO Drug) coding for clinical and post‑marketing safety data.
* Demonstrate knowledge of current global PV regulations and guidelines (CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards.
* Offer safety expertise to due diligence activities as needed.
* Keep abreast of new PV/safety regulations and guidance from regulatory authorities.
Required Knowledge, Skills, And Abilities
* Minimum 2‑5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered.
* Excellent knowledge of the drug development process.
* High level of initiative and independence.
* Excellent written and oral communication skills, resourcefulness and personal organization, 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.
Leadership Skills
* Enterprise and proactive mindset—collaborative spirit and benefit of cross‑functional work.
* Set and achieve goals, translating business objectives into strategies and navigating obstacles.
* Inspire and mobilize others, serving as a positive role model and influencing teams across the organization.
* Understanding of target product profile, clinical designs and global PV regulatory environment with knowledge of international regulations and Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP).
* Preferred exposure to working relationships with FDA, EMA and other regulatory authorities.
* Knowledge of safety databases (ARISg, ARGUS, or other) and electronic data capture systems is a plus.
* Training in MedDRA and WHO Drug coding dictionaries is a plus.
* Ability to manage multiple tasks with deadlines in a fast‑paced environment.
Required/Preferred Education And Licenses
* MD required; medical licensure in at least one region preferred. Clinical research and/fellowship training in internal medicine, neurology, or other relevant specialty is a plus.
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.
FOR US‑BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and strives to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $240,000.00 – $360,000.00. Individual compensation within this range will depend on qualifications, skills, experience, and other 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. Internal equity considerations will also influence individual base pay decisions, and the range will be reviewed regularly. In addition, the successful candidate may be eligible for discretionary annual cash bonuses, incentive compensation, and discretionary equity grants, in accordance with Jazz’s compensation plans. Eligible employees also have access to benefits including medical, dental, vision, 401(k), and paid vacation. For more information on the benefits package, visit Jazz Benefits.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Management and Manufacturing
Industries
Pharmaceutical Manufacturing
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