Associate Medical Director, Medical Safety
Jazz Pharmaceuticals
August 19, 2026
Remote friendly (Philadelphia, PA)
United States
Medical Affairs
If you are a current Jazz employee please apply via the Internal Career site.
Associate Medical Director / Global Safety Physician
Responsibilities:
- Implement global safety strategy and monitor overall product safety lifecycle (investigational/marketed).
- Generate major pre-/post-marketing safety deliverables (signal detection/evaluation, benefit-risk, risk management) and prepare safety reports; communicate changes in product risk profile.
- Provide Medical Safety/PV inputs for assigned products across clinical development, investigator-sponsored/compassionate use/disease monitoring programs; liaise with cross-functional partners and external stakeholders.
- Support global launch activities with Medical Safety/PV inputs.
- Participate in review of safety-related sections for clinical/regulatory/scientific documents (protocols, consent/assent, CRFs, statistical plans, CSR/synopses, integrated safety summaries, NDA/BLA, MAA, CTD, IRB/EC requests, briefing books, manuscripts).
- Ensure CCSI implementation across RSI; review relevant literature; conduct and document signal detection and safety assessments.
- Chair Safety Management Team; oversee aggregate safety report signatory/review (PSUR/PBRER, PADER, DSUR, IND Annual Report, 6-month SUSAR line listings).
- Contribute to Risk Management Plans; provide MedDRA/WHODrug coding guidance; ensure PV regulatory compliance and inspection readiness.
Required:
- MD required (or equivalent); medical licensure in at least one state preferred.
- 3+ years Drug Safety/Pharmacovigilance (or 3+ years clinical development).
Skills/Qualifications:
- Working knowledge of global PV regulations/GVP and case processing; safety databases (e.g., ARISg/ARGUS) and EDC systems.
- MedDRA trained; knowledge of MedDRA/WHO Drug coding dictionaries.
- Excellent written/oral communication; cross-functional teamwork; manage multiple deadlines; computer literacy (Excel/PowerPoint/Word).
Benefits (US): medical/dental/vision, 401k, flexible paid vacation; potential annual cash bonus/incentive and discretionary equity grants.
Associate Medical Director / Global Safety Physician
Responsibilities:
- Implement global safety strategy and monitor overall product safety lifecycle (investigational/marketed).
- Generate major pre-/post-marketing safety deliverables (signal detection/evaluation, benefit-risk, risk management) and prepare safety reports; communicate changes in product risk profile.
- Provide Medical Safety/PV inputs for assigned products across clinical development, investigator-sponsored/compassionate use/disease monitoring programs; liaise with cross-functional partners and external stakeholders.
- Support global launch activities with Medical Safety/PV inputs.
- Participate in review of safety-related sections for clinical/regulatory/scientific documents (protocols, consent/assent, CRFs, statistical plans, CSR/synopses, integrated safety summaries, NDA/BLA, MAA, CTD, IRB/EC requests, briefing books, manuscripts).
- Ensure CCSI implementation across RSI; review relevant literature; conduct and document signal detection and safety assessments.
- Chair Safety Management Team; oversee aggregate safety report signatory/review (PSUR/PBRER, PADER, DSUR, IND Annual Report, 6-month SUSAR line listings).
- Contribute to Risk Management Plans; provide MedDRA/WHODrug coding guidance; ensure PV regulatory compliance and inspection readiness.
Required:
- MD required (or equivalent); medical licensure in at least one state preferred.
- 3+ years Drug Safety/Pharmacovigilance (or 3+ years clinical development).
Skills/Qualifications:
- Working knowledge of global PV regulations/GVP and case processing; safety databases (e.g., ARISg/ARGUS) and EDC systems.
- MedDRA trained; knowledge of MedDRA/WHO Drug coding dictionaries.
- Excellent written/oral communication; cross-functional teamwork; manage multiple deadlines; computer literacy (Excel/PowerPoint/Word).
Benefits (US): medical/dental/vision, 401k, flexible paid vacation; potential annual cash bonus/incentive and discretionary equity grants.