Associate Medical Director, Medical Safety
Jazz Pharmaceuticals
6 months ago
Remote friendly (Palo Alto, CA)
United States
Medical Affairs
Associate Medical Director / Global Safety Physician
Responsibilities:
- Implement the global safety strategy and monitor overall safety profile for investigational and marketed products across their lifecycle.
- Generate major pre- and post-marketing safety deliverables (e.g., signal detection, benefit-risk evaluation, risk management activities).
- Interface cross-functionally (at all levels) and with external Regulatory Authorities.
- Under supervision, work with PV staff on safety assessments: review aggregate safety analyses and scientific literature; prepare safety reports; communicate changes in product risk profile.
- Provide Medical Safety/PV inputs to assigned products (including Clinical Development programs and Investigator-Sponsored, Compassionate Use, and Disease Monitoring Programs) and liaise with key internal/external stakeholders to ensure safety strategy and operational excellence.
- Provide Medical Safety/PV inputs to support global launch activities.
- Prepare/review safety-related sections of clinical, regulatory, and scientific documents (protocols, IC/IA, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, IRB/EC requests, briefing books, manuscripts, and articles).
- Collaborate on CCSI creation/maintenance and ensure implementation in reference safety information (IBs, CCDS, national labels, labeling).
- Review medical/scientific literature for signal detection and aggregate reporting.
- Conduct signal detection and analyses; interpret safety signals/trends; document and communicate safety assessments.
- Chair the Safety Management Team (SMT) for assigned products; participate in executive forums.
- Oversee preparation/review of aggregate safety reports (PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, 6-month SUSAR line listing reports) and ensure consistent regulatory communication.
- Contribute to Risk Management Plans (RMPs).
- Guide adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data.
- Ensure compliance with global PV regulations/guidelines (CIOMS, EMA, FDA, ICH), SOPs, and quality standards; support inspection readiness, internal audits, and external inspections.
- Represent PV in cross-functional forums; contribute to PV KPIs.
- Maintain knowledge of assigned product indications and keep abreast of PV/safety regulatory guidance.
Required Knowledge, Skills, and Abilities:
- Working knowledge of global PV regulatory environment and Good Pharmacovigilance Practices (GVP), including case processing.
- Working knowledge of safety databases (ARISg, ARGUS, or similar) and electronic data capture systems.
- MedDRA training and working knowledge of MedDRA and WHO drug coding dictionaries.
- Preferred: experience with PV audit process and active participation in Regulatory Authority Inspections.
- Ability to manage multiple tasks with deadlines in a fast-paced environment.
- Knowledge of drug development process; high initiative and independence.
- Excellent written/oral communication, organization, and cross-functional teamwork.
- Computer literacy: regulatory databases and Microsoft Excel, PowerPoint, Word.
- Some national/international travel may be required.
Education/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 other 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 (US candidates only, if applicable):
- Base pay range: $212,000.00 - $318,000.00
- Discretionary annual cash bonus/incentive compensation (depending on role) and discretionary equity grants.
- Medical, dental, and vision insurance; 401k retirement savings plan; flexible paid vacation.
Application instructions:
- If you are a current Jazz employee, apply via the Internal Career site.
Responsibilities:
- Implement the global safety strategy and monitor overall safety profile for investigational and marketed products across their lifecycle.
- Generate major pre- and post-marketing safety deliverables (e.g., signal detection, benefit-risk evaluation, risk management activities).
- Interface cross-functionally (at all levels) and with external Regulatory Authorities.
- Under supervision, work with PV staff on safety assessments: review aggregate safety analyses and scientific literature; prepare safety reports; communicate changes in product risk profile.
- Provide Medical Safety/PV inputs to assigned products (including Clinical Development programs and Investigator-Sponsored, Compassionate Use, and Disease Monitoring Programs) and liaise with key internal/external stakeholders to ensure safety strategy and operational excellence.
- Provide Medical Safety/PV inputs to support global launch activities.
- Prepare/review safety-related sections of clinical, regulatory, and scientific documents (protocols, IC/IA, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, IRB/EC requests, briefing books, manuscripts, and articles).
- Collaborate on CCSI creation/maintenance and ensure implementation in reference safety information (IBs, CCDS, national labels, labeling).
- Review medical/scientific literature for signal detection and aggregate reporting.
- Conduct signal detection and analyses; interpret safety signals/trends; document and communicate safety assessments.
- Chair the Safety Management Team (SMT) for assigned products; participate in executive forums.
- Oversee preparation/review of aggregate safety reports (PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, 6-month SUSAR line listing reports) and ensure consistent regulatory communication.
- Contribute to Risk Management Plans (RMPs).
- Guide adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data.
- Ensure compliance with global PV regulations/guidelines (CIOMS, EMA, FDA, ICH), SOPs, and quality standards; support inspection readiness, internal audits, and external inspections.
- Represent PV in cross-functional forums; contribute to PV KPIs.
- Maintain knowledge of assigned product indications and keep abreast of PV/safety regulatory guidance.
Required Knowledge, Skills, and Abilities:
- Working knowledge of global PV regulatory environment and Good Pharmacovigilance Practices (GVP), including case processing.
- Working knowledge of safety databases (ARISg, ARGUS, or similar) and electronic data capture systems.
- MedDRA training and working knowledge of MedDRA and WHO drug coding dictionaries.
- Preferred: experience with PV audit process and active participation in Regulatory Authority Inspections.
- Ability to manage multiple tasks with deadlines in a fast-paced environment.
- Knowledge of drug development process; high initiative and independence.
- Excellent written/oral communication, organization, and cross-functional teamwork.
- Computer literacy: regulatory databases and Microsoft Excel, PowerPoint, Word.
- Some national/international travel may be required.
Education/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 other 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 (US candidates only, if applicable):
- Base pay range: $212,000.00 - $318,000.00
- Discretionary annual cash bonus/incentive compensation (depending on role) and discretionary equity grants.
- Medical, dental, and vision insurance; 401k retirement savings plan; flexible paid vacation.
Application instructions:
- If you are a current Jazz employee, apply via the Internal Career site.