Associate Medical Director, Medical Safety
Jazz Pharmaceuticals
August 18, 2026
Remote friendly (California, United States)
United States
Medical Affairs
Responsibilities:
- Implement global safety strategy and monitor overall safety profile for investigational and marketed products throughout lifecycle.
- Generate pre- and post-marketing safety deliverables (signal detection, benefit-risk evaluation, risk management).
- Interface cross-functionally and with external Regulatory Authorities.
- Manage safety assessment activities: review aggregate safety analyses/scientific literature, prepare safety reports, and communicate changes in product risk profile.
- Provide Medical Safety/PV inputs to clinical development, investigator-sponsored programs, compassionate use, and disease monitoring programs; liaise with study and safety stakeholders (Clinical Sciences/Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs).
- Support global launch activities with PV/medical safety inputs.
- Prepare/review safety sections for clinical, regulatory, and scientific documents (protocols, consent forms, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts).
- Maintain Company Core Safety Information (CCSI) implementation across RSI/labeling; review relevant literature for signals.
- Conduct signal detection, evaluation, validation, and communicate safety assessments.
- Chair Safety Management Team (SMT); oversee preparation/review of aggregate safety reports (PSUR/PBRER, PADER, DSUR, IND Annual Reports, 6-month SUSAR line listings).
- Contribute to Risk Management Plans (RMPs); guide MedDRA/WHODrug coding.
- Ensure compliance with PV regulations/guidelines and support audits/inspections.
- Represent PV in cross-functional forums; contribute to PV KPIs; stay current on PV guidance.
Required:
- MD (or equivalent); medical licensure in at least one state preferred.
- Minimum 3 years Drug Safety/Pharmacovigilance or 3+ years clinical development.
Required Skills/Abilities:
- Working knowledge of global PV regulatory environment and Good Pharmacovigilance Practices (GVP).
- Working knowledge of safety databases (e.g., ARISg/ARGUS) and electronic data capture.
- MedDRA training and coding dictionary knowledge.
- Ability to manage multiple deadlines; strong written/oral communication and cross-functional teamwork.
- Computer literacy (Regulatory databases, Excel, PowerPoint, Word); some travel possible.
Benefits (US candidates): medical/dental/vision insurance, 401(k), flexible paid vacation; discretionary bonus/incentive and potential equity grants.
- Implement global safety strategy and monitor overall safety profile for investigational and marketed products throughout lifecycle.
- Generate pre- and post-marketing safety deliverables (signal detection, benefit-risk evaluation, risk management).
- Interface cross-functionally and with external Regulatory Authorities.
- Manage safety assessment activities: review aggregate safety analyses/scientific literature, prepare safety reports, and communicate changes in product risk profile.
- Provide Medical Safety/PV inputs to clinical development, investigator-sponsored programs, compassionate use, and disease monitoring programs; liaise with study and safety stakeholders (Clinical Sciences/Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs).
- Support global launch activities with PV/medical safety inputs.
- Prepare/review safety sections for clinical, regulatory, and scientific documents (protocols, consent forms, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts).
- Maintain Company Core Safety Information (CCSI) implementation across RSI/labeling; review relevant literature for signals.
- Conduct signal detection, evaluation, validation, and communicate safety assessments.
- Chair Safety Management Team (SMT); oversee preparation/review of aggregate safety reports (PSUR/PBRER, PADER, DSUR, IND Annual Reports, 6-month SUSAR line listings).
- Contribute to Risk Management Plans (RMPs); guide MedDRA/WHODrug coding.
- Ensure compliance with PV regulations/guidelines and support audits/inspections.
- Represent PV in cross-functional forums; contribute to PV KPIs; stay current on PV guidance.
Required:
- MD (or equivalent); medical licensure in at least one state preferred.
- Minimum 3 years Drug Safety/Pharmacovigilance or 3+ years clinical development.
Required Skills/Abilities:
- Working knowledge of global PV regulatory environment and Good Pharmacovigilance Practices (GVP).
- Working knowledge of safety databases (e.g., ARISg/ARGUS) and electronic data capture.
- MedDRA training and coding dictionary knowledge.
- Ability to manage multiple deadlines; strong written/oral communication and cross-functional teamwork.
- Computer literacy (Regulatory databases, Excel, PowerPoint, Word); some travel possible.
Benefits (US candidates): medical/dental/vision insurance, 401(k), flexible paid vacation; discretionary bonus/incentive and potential equity grants.