Jazz Pharmaceuticals
Medical Director, Medical Safety
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Global Safety Physician – Jazz Pharmaceuticals
If you are a current Jazz employee please apply via the Internal Career site.
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 growing oncology treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our pipeline in oncology and neuroscience.
Headquartered in Dublin, Ireland, we operate global R&D labs, manufacturing facilities and employ teams worldwide in service of patients around the globe. Learn more at www.jazzpharmaceuticals.com.
About the Role
The Global Safety Physician serves as the safety expert responsible for the global safety strategy across Jazz Pharmaceuticals’ investigational and marketed products throughout their lifecycle. This role involves overseeing pivotal pre-market and post-market safety activities, such as signal detection, benefit-risk evaluation, and risk management. The incumbent must collaborate cross-functionally with internal teams and external Regulatory Authorities, ensuring close alignment with global Pharmacovigilance (PV) obligations.
Key Responsibilities
- Lead and oversee safety-related documentation for assigned therapies, including but not limited to:
- Regulatory submissions (IND/BLA/NDA, MAAs, CTDs)
- Safety clinical trial protocols, CRFs, and CSRs
- SUSAR reports, literature reviews, and drug safety signaling
- Serve as global safety representative on:
- Regulatory Teams
- Development Core Teams
- Safety Management Teams for specified products
- Collaborate with the REMS team to refine product risk mitigation strategies
- Develop and maintain Core Safety Information (CCSI) and its implementation across Investigator Reports, clinical documentation, and labeling
- Detect, evaluate, and communicate safety signals through aggregated data, trend analyses, and external literature tracking
- Contribute to risk management plans aligned with ICH/EMA/FDA guidelines (e.g., Conditional Approval frameworks)
- Codec and review adverse events through appropriate MedDRA and WHO Drug Dictionary methodologies and format regulatory agency requests
- Support regulatory due diligence, ensuring compliance with emerging global PV regulations
- Stay abreast of evolving regulatory guidance and best practices
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Essential Requirements
Experience & Qualifications
- Minimum 2–5 years of experience in clinical development, medical affairs, or Drug Safety/Pharmacovigilance, with possible consideration for alternate medical affairs significant involvement
- Deep understanding of pharmaceutical development lifecycle, Global PV processes, and best practices (GCP, GVP)
- Strong regulatory knowledge, with exposure to FDA, EMA, ICH, and REMS protocols [preferred]
Technical Proficiencies
- Essential:
- Proficiency in Excel, PowerPoint, Word
- Working competence with external Regulatory Databases
- Strong written/verbal communication skills with clear and adaptable cross-team collaboration
- Ability to navigate fast-paced environments, support signal detection methodologies, and navigate complex stakeholder relationships
- Preferred:
- Experience with MedDRA coding and familiarity with platforms such as MedDRA/WHO Drug dictionaries
- Knowledge of ARISg/ARGUS or equivalent safety databases
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Licensure
- MD, MBA, or Doctoral degree in a clinical discipline required
- Licensed medical specialist in **at least one jurisdiction preferred
- Advanced qualifications in Oncology, Neurology, Pulmonology, or another relevant specialty helpful
Leadership & Attributes
Despite seniority and independence, this position requires aspiring leadership. Ideal candidates exemplify: ✔ Collaborative mindset ✔ Goal orientation with pragmatic, problem-solving skills ✔ Creative influence and uplifting leadership ✔ Cultural adaptability to working across multiple geographies and functional teams
Remuneration & Benefits
For U.S.-based candidates, base pay for this role ranges between $256,000.00 and $384,000.00 depending on qualifications and experience. Compensation may also include:
- Discretionary bonus/long-term incentives
- Eligibility for equity grants via Jazz’s Long-Term Equity Incentive Program
- Comprehensive benefits including medical/dental/vision coverage, a 401k plan, and flexible paid time.
Full compensation details and benefits overview available here.
Compliance & Commitment
Jazz is an equal-opportunity workplace. All qualified applicants will be given fair consideration regardless of race, color, religion, sex, national origin, disability, veteran status, or any law-protected classification.
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