Associate Medical Director, Medical Safety
Jazz Pharmaceuticals
6 months ago
Remote friendly (California, United States)
United States
Medical Affairs
1 Essential Functions/Responsibilities
- Implement the global safety strategy and monitor the overall safety profile for investigational and marketed products throughout the lifecycle.
- Generate major pre- and post-marketing safety deliverables, including signal detection, benefit-risk evaluation, and risk management activities.
- Interface cross-functionally and with external Regulatory Authorities to manage safety assessments (aggregate safety analyses and scientific literature), prepare safety reports, and communicate changes in product risk profile.
- Provide Medical Safety/PV inputs for assigned products across Clinical Development, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, and others to ensure safety strategy and operational excellence.
- Support global launch activities with Medical Safety/PV inputs.
- Prepare and review safety-related sections for clinical, regulatory, and scientific documents (e.g., protocols, informed consent/assent, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, IRB/EC requests, briefing books, manuscripts, journal articles).
- Collaborate on Company Core Safety Information (CCSI) and ensure implementation in Reference Safety Information (RSI) and labeling.
- Conduct medical/scientific literature review for signal detection and aggregate reporting.
- Perform signal detection and communicate safety assessments (written/verbal).
- Chair the Safety Management Team (SMT) and participate in executive forums.
- Oversee pre- and postmarketing aggregate safety reports (PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, 6-month SUSAR line listings).
- Contribute to Risk Management Plans (RMPs).
- Provide guidance on MedDRA and WHODrug coding.
- Ensure compliance with global PV regulations/guidelines, SOPs, and quality standards; support inspections/audits.
- Represent PV in cross-functional committees; contribute to PV key performance indicators.
Required Knowledge, Skills, and Abilities
- Working knowledge of global PV regulatory environment and Good Pharmacovigilance Practices (GVP) (Americas/EU case processing and pharmacovigilance processes).
- Safety database and electronic data capture system knowledge (e.g., ARISg, ARGUS).
- MedDRA trained; working knowledge of MedDRA and WHO Drug coding.
- PV audit experience with participation in Regulatory Authority Inspections (preferred).
- Ability to manage multiple tasks with deadlines in a fast-paced environment.
- Knowledge of the drug development process.
- High initiative and independence; excellent written/oral communication and cross-functional teamwork.
- Computer literacy (external Regulatory Databases, MS Excel/PowerPoint/Word).
- Some national/international travel may be 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 or neuroscience, hematology/oncology (or relevant specialty) is a plus.
- Minimum 3 years Drug Safety/Pharmacovigilance (PV) experience OR 3+ years clinical development experience (other relevant experience may be considered).
Benefits / Compensation (US candidates only)
- Base pay range: $212,000.00 - $318,000.00.
- Eligible for discretionary annual cash bonus/incentive (depending on role) and discretionary equity grants.
- Eligible for medical, dental, vision insurance, 401k retirement savings plan, and flexible paid vacation.
- Implement the global safety strategy and monitor the overall safety profile for investigational and marketed products throughout the lifecycle.
- Generate major pre- and post-marketing safety deliverables, including signal detection, benefit-risk evaluation, and risk management activities.
- Interface cross-functionally and with external Regulatory Authorities to manage safety assessments (aggregate safety analyses and scientific literature), prepare safety reports, and communicate changes in product risk profile.
- Provide Medical Safety/PV inputs for assigned products across Clinical Development, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, and others to ensure safety strategy and operational excellence.
- Support global launch activities with Medical Safety/PV inputs.
- Prepare and review safety-related sections for clinical, regulatory, and scientific documents (e.g., protocols, informed consent/assent, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, IRB/EC requests, briefing books, manuscripts, journal articles).
- Collaborate on Company Core Safety Information (CCSI) and ensure implementation in Reference Safety Information (RSI) and labeling.
- Conduct medical/scientific literature review for signal detection and aggregate reporting.
- Perform signal detection and communicate safety assessments (written/verbal).
- Chair the Safety Management Team (SMT) and participate in executive forums.
- Oversee pre- and postmarketing aggregate safety reports (PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, 6-month SUSAR line listings).
- Contribute to Risk Management Plans (RMPs).
- Provide guidance on MedDRA and WHODrug coding.
- Ensure compliance with global PV regulations/guidelines, SOPs, and quality standards; support inspections/audits.
- Represent PV in cross-functional committees; contribute to PV key performance indicators.
Required Knowledge, Skills, and Abilities
- Working knowledge of global PV regulatory environment and Good Pharmacovigilance Practices (GVP) (Americas/EU case processing and pharmacovigilance processes).
- Safety database and electronic data capture system knowledge (e.g., ARISg, ARGUS).
- MedDRA trained; working knowledge of MedDRA and WHO Drug coding.
- PV audit experience with participation in Regulatory Authority Inspections (preferred).
- Ability to manage multiple tasks with deadlines in a fast-paced environment.
- Knowledge of the drug development process.
- High initiative and independence; excellent written/oral communication and cross-functional teamwork.
- Computer literacy (external Regulatory Databases, MS Excel/PowerPoint/Word).
- Some national/international travel may be 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 or neuroscience, hematology/oncology (or relevant specialty) is a plus.
- Minimum 3 years Drug Safety/Pharmacovigilance (PV) experience OR 3+ years clinical development experience (other relevant experience may be considered).
Benefits / Compensation (US candidates only)
- Base pay range: $212,000.00 - $318,000.00.
- Eligible for discretionary annual cash bonus/incentive (depending on role) and discretionary equity grants.
- Eligible for medical, dental, vision insurance, 401k retirement savings plan, and flexible paid vacation.