Associate Medical Director, Medical Safety
Jazz Pharmaceuticals
August 20, 2026
Remote friendly (Palo Alto, CA)
United States
Medical Affairs
Associate Medical Director / Global Safety Physician
Responsibilities:
- Implement global safety strategy and monitor overall safety profile for Jazz products (investigational and marketed) throughout the lifecycle.
- Generate major pre- and post-marketing safety deliverables, including signal detection, benefit-risk evaluation, and risk management.
- Interface cross-functionally and with external Regulatory Authorities; support safety assessment activities (aggregate safety analyses and scientific literature), safety report preparation, and communication of changes in product risk profile.
- Provide Medical Safety/PV inputs to assigned programs and liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, etc.
- Provide Medical Safety/PV inputs to Commercial launch activities.
- Contribute to preparation/review of safety sections for protocols, informed consent/assent, CRFs, statistical plans, clinical study reports, integrated safety summaries, NDA/BLA, MAA, CTD submissions, agency responses, IRB/EC requests, briefing books, and publications.
- Collaborate on Company Core Safety Information (CCSI) and labeling updates; ensure implementation in Investigator Brochures, CCDS, national labels, and other product labeling.
- Perform literature review for signal detection; conduct signal detection and assessment documentation/communication.
- Chair Safety Management Team (SMT) and participate in executive forums.
- Oversee preparation/review of aggregate safety reports (PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, SUSAR Line Listing Reports).
- Contribute to Risk Management Plans (RMPs).
- Provide guidance on MedDRA and WHODrug coding.
- Ensure compliance with global PV regulations/guidelines (CIOMS, EMA, FDA, ICH), SOPs, quality standards; support inspection readiness.
- Represent PV in cross-functional forums; contribute to PV KPIs; keep abreast of PV/safety regulatory updates.
Required:
- MD (or equivalent); medical licensure in at least one state preferred.
- Minimum 3 years Drug Safety/Pharmacovigilance experience (or 3+ years clinical development).
- Strong written/oral communication and cross-functional teamwork.
Skills/Qualifications:
- Working knowledge of global PV regulatory environment and GVP; case processing and PV processes.
- Knowledge of safety databases (ARISg, ARGUS or others) and eCAP systems.
- MedDRA trained; working knowledge of MedDRA and WHO Drug dictionaries.
- Preferred: PV audit experience with participation in Regulatory Authority Inspections.
- Computer literacy (Regulatory databases, Excel, PowerPoint, Word); ability to manage multiple deadlines; drug development knowledge; initiative/independence.
- Some national/international travel may be required.
Responsibilities:
- Implement global safety strategy and monitor overall safety profile for Jazz products (investigational and marketed) throughout the lifecycle.
- Generate major pre- and post-marketing safety deliverables, including signal detection, benefit-risk evaluation, and risk management.
- Interface cross-functionally and with external Regulatory Authorities; support safety assessment activities (aggregate safety analyses and scientific literature), safety report preparation, and communication of changes in product risk profile.
- Provide Medical Safety/PV inputs to assigned programs and liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, etc.
- Provide Medical Safety/PV inputs to Commercial launch activities.
- Contribute to preparation/review of safety sections for protocols, informed consent/assent, CRFs, statistical plans, clinical study reports, integrated safety summaries, NDA/BLA, MAA, CTD submissions, agency responses, IRB/EC requests, briefing books, and publications.
- Collaborate on Company Core Safety Information (CCSI) and labeling updates; ensure implementation in Investigator Brochures, CCDS, national labels, and other product labeling.
- Perform literature review for signal detection; conduct signal detection and assessment documentation/communication.
- Chair Safety Management Team (SMT) and participate in executive forums.
- Oversee preparation/review of aggregate safety reports (PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, SUSAR Line Listing Reports).
- Contribute to Risk Management Plans (RMPs).
- Provide guidance on MedDRA and WHODrug coding.
- Ensure compliance with global PV regulations/guidelines (CIOMS, EMA, FDA, ICH), SOPs, quality standards; support inspection readiness.
- Represent PV in cross-functional forums; contribute to PV KPIs; keep abreast of PV/safety regulatory updates.
Required:
- MD (or equivalent); medical licensure in at least one state preferred.
- Minimum 3 years Drug Safety/Pharmacovigilance experience (or 3+ years clinical development).
- Strong written/oral communication and cross-functional teamwork.
Skills/Qualifications:
- Working knowledge of global PV regulatory environment and GVP; case processing and PV processes.
- Knowledge of safety databases (ARISg, ARGUS or others) and eCAP systems.
- MedDRA trained; working knowledge of MedDRA and WHO Drug dictionaries.
- Preferred: PV audit experience with participation in Regulatory Authority Inspections.
- Computer literacy (Regulatory databases, Excel, PowerPoint, Word); ability to manage multiple deadlines; drug development knowledge; initiative/independence.
- Some national/international travel may be required.