Associate Medical Director, Medical Safety

Company Overview

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. Our portfolio includes leading therapies for sleep disorders and epilepsy, and a growing pipeline of cancer treatments and neuroscience products. Jazz is headquartered in Dublin, Ireland with R&D laboratories, manufacturing facilities and employees in multiple countries.

If you are a current Jazz employee please apply via the Internal Career site.

Responsibilities

• Implement the global safety strategy and monitor the overall safety profile for Jazz products throughout their lifecycle.
• Generate all major pre‑ and post‑marketing safety deliverables, including signal detection, benefit‑risk evaluation, and risk management activities.
• Coordinate with cross‑functional teams (Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, etc.) and external regulatory authorities to manage safety assessments.
• Prepare and review safety‑related sections for clinical, regulatory, and scientific documents such as protocols, informed consent forms, case report forms, statistical plans, clinical study reports, integrated safety summaries, NDA/BLA and MAA submissions, regulatory agency responses, IRB/EC requests, briefing books, manuscripts, and journal articles.
• Contribute to the creation and maintenance of Company Core Safety Information (CCSI) and collaborate with the Labeling Committee to incorporate CCSI into reference safety information and product labeling.
• Review medical and scientific literature for signal detection and aggregate reporting; conduct signal detection activities, interpret safety signals, and communicate assessments to internal and external stakeholders.
• Chair the Safety Management Team for assigned products and participate in executive forums.
• Signify and oversee the preparation of aggregate safety reports (PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, SUSAR Line‑Listing Reports) and ensure consistent communication across regulatory documents.
• Contribute to the development of Risk Management Plans, ensuring risks are identified and mitigated per regulatory requirements.
• Provide guidance on adverse event coding (MedDRA) and drug coding (WHO Drug) for clinical and post‑marketing data.
• Ensure compliance with global PV regulations, SOPs, and quality standards; participate in inspection readiness activities, internal audits, and external inspections.
• Represent PV in cross‑functional forums and committees to achieve the company’s goals.
• Maintain knowledge of Jazz product indications and stay abreast of new PV regulations and guidance.

Knowledge, Skills, and Abilities

• Deep understanding of global PV regulatory environment and Good Pharmacovigilance Practice (GVP) standards in the Americas and EU.
• Experience with safety databases (ARISg, ARGUS, or similar) and electronic data capture systems.
• MedDRA training and proficiency in MedDRA and WHO Drug coding dictionaries.
• Experience with PV audit processes and participation in regulatory authority inspections.
• Strong organizational and time‑management skills in a fast‑paced environment.
• Knowledge of the drug development process and multidisciplinary teamwork.
• Excellent written and oral communication skills.
• Computer literacy with proficiency in regulatory databases, Microsoft Excel, PowerPoint, and Word.
• Ability to travel internationally or nationally 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, neuroscience, hematology/oncology, or another relevant specialty is a plus.
• Minimum 3 years of Drug Safety/Pharmacovigilance experience or 3+ years in clinical development.

Compensation and Benefits

• US‑based candidates only: base salary range $212,000 – $318,000, adjusted for qualifications and experience.
• Eligible for discretionary annual cash bonus or incentive compensation per company plans.
• Eligible for discretionary equity grants under the Long‑Term Equity Incentive Plan.
• Comprehensive benefits package including medical, dental, vision, 401(k), and flexible paid vacation.

EEO Statement

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.