Associate Medical Director, Medical Safety
Jazz Pharmaceuticals
September 01, 2026
Remote friendly (Carlsbad, CA)
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 safety profile for investigational and marketed products throughout the lifecycle.
- Manage safety assessments with PV staff: review aggregate safety analyses and literature; prepare safety reports; communicate changes in product risk profile.
- Provide Medical Safety/PV inputs to assigned products across clinical development (all phases), Investigator-Sponsored, Compassionate Use, and Disease Monitoring programs; liaise with cross-functional teams and external parties (e.g., CROs, DMCs).
- Support commercial launch activities for assigned products.
- Contribute to safety sections of protocols, informed consent/assent, CRFs, statistical plans, clinical study reports, integrated safety summaries, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, and scientific manuscripts.
- Maintain Company Core Safety Information (CCSI) and ensure implementation in reference safety information.
- Conduct signal detection and risk/benefit evaluation; chair Safety Management Team (SMT) for assigned products.
- Oversee preparation/review of aggregate safety reports (e.g., PSUR/PBRER, PADER, DSUR, IND Annual, SUSAR line listings) and support Risk Management Plans; advise on MedDRA/WHO drug coding.
Required/Preferred Knowledge & Skills:
- Global PV regulations/GVP; safety database and eDC systems; MedDRA/WHO drug coding.
- Strong communication, organization, cross-functional teamwork; ability to meet deadlines; computer skills (Excel/PowerPoint/Word). Travel may be required.
Education/Licenses:
- MD required (or equivalent); licensure in at least one state preferred.
- Minimum 3 years Drug Safety/PV experience or 3+ years clinical development (other relevant experience considered).
US Benefits/Comp (if applicable):
- Base pay range: $212,000–$318,000; eligible for discretionary bonus/incentives/equity grants and benefits (medical/dental/vision, 401k, flexible paid vacation).
Associate Medical Director / Global Safety Physician
Responsibilities:
- Implement global safety strategy and monitor overall safety profile for investigational and marketed products throughout the lifecycle.
- Manage safety assessments with PV staff: review aggregate safety analyses and literature; prepare safety reports; communicate changes in product risk profile.
- Provide Medical Safety/PV inputs to assigned products across clinical development (all phases), Investigator-Sponsored, Compassionate Use, and Disease Monitoring programs; liaise with cross-functional teams and external parties (e.g., CROs, DMCs).
- Support commercial launch activities for assigned products.
- Contribute to safety sections of protocols, informed consent/assent, CRFs, statistical plans, clinical study reports, integrated safety summaries, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, and scientific manuscripts.
- Maintain Company Core Safety Information (CCSI) and ensure implementation in reference safety information.
- Conduct signal detection and risk/benefit evaluation; chair Safety Management Team (SMT) for assigned products.
- Oversee preparation/review of aggregate safety reports (e.g., PSUR/PBRER, PADER, DSUR, IND Annual, SUSAR line listings) and support Risk Management Plans; advise on MedDRA/WHO drug coding.
Required/Preferred Knowledge & Skills:
- Global PV regulations/GVP; safety database and eDC systems; MedDRA/WHO drug coding.
- Strong communication, organization, cross-functional teamwork; ability to meet deadlines; computer skills (Excel/PowerPoint/Word). Travel may be required.
Education/Licenses:
- MD required (or equivalent); licensure in at least one state preferred.
- Minimum 3 years Drug Safety/PV experience or 3+ years clinical development (other relevant experience considered).
US Benefits/Comp (if applicable):
- Base pay range: $212,000–$318,000; eligible for discretionary bonus/incentives/equity grants and benefits (medical/dental/vision, 401k, flexible paid vacation).