Associate Medical Director, Medical Safety
Jazz Pharmaceuticals
6 months ago
Remote friendly (Philadelphia, PA)
United States
Medical Affairs
1 Essential Functions/Responsibilities
- Implement global safety strategy and monitor 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.
- Interface cross-functionally across the organization and with external Regulatory Authorities.
- With PV staff, manage safety assessment of products: review aggregate safety analyses and scientific literature; prepare safety reports; communicate changes in product risk profile to internal/external stakeholders.
- Provide Medical Safety/PV inputs to assigned products and liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, and other entities to ensure safety strategy and operational excellence.
- Provide Medical Safety/PV inputs to the Commercial organization to support global launch activities.
- Prepare and review safety-related sections for clinical, regulatory, and scientific documents (e.g., protocols, consent/assent, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts).
- Collaborate on Company Core Safety Information (CCSI) and ensure implementation in Reference Safety Information (RSI), including Investigator Brochures, Company Core Data Sheet, and other labeling.
- Perform literature review for signal detection and aggregate reporting.
- Conduct signal detection/assessment: individual and aggregate analyses; interpret safety signals/trends; document and communicate safety assessments.
- Chair 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 listings).
- Contribute to Risk Management Plans (RMPs).
- Provide guidance on MedDRA and WHODrug coding for safety data.
- Ensure compliance with global PV regulations/guidelines (e.g., CIOMS, EMA, FDA, ICH) and SOPs; 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.
- Safety database knowledge (e.g., ARISg/ARGUS) and electronic data capture systems.
- MedDRA training and knowledge of MedDRA/WHO Drug coding dictionaries.
- PV audit experience and active participation in Regulatory Authority Inspections (preferred).
- Ability to manage multiple tasks with deadlines in a fast-paced environment.
- Knowledge of drug development process.
- Initiative and independence.
- Excellent written/oral communication, organization, and cross-functional teamwork.
- Computer literacy (Regulatory Databases; Microsoft Excel, PowerPoint, Word).
- Some national/international travel may be required.
Required/Preferred 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 other relevant specialty is a plus.
- Minimum 3 years Drug Safety/Pharmacovigilance experience OR 3+ years clinical development experience (other relevant experience may be considered).
Benefits (if part of the job description)
- Base pay range (US): $212,000.00 - $318,000.00.
- Discretionary annual cash bonus/incentive (depending on role) and discretionary equity grants.
- Medical, dental, vision insurance, 401k retirement savings plan, and flexible paid vacation.
Application instructions
- If you are a current Jazz employee: apply via the Internal Career site.
- Implement global safety strategy and monitor 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.
- Interface cross-functionally across the organization and with external Regulatory Authorities.
- With PV staff, manage safety assessment of products: review aggregate safety analyses and scientific literature; prepare safety reports; communicate changes in product risk profile to internal/external stakeholders.
- Provide Medical Safety/PV inputs to assigned products and liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, and other entities to ensure safety strategy and operational excellence.
- Provide Medical Safety/PV inputs to the Commercial organization to support global launch activities.
- Prepare and review safety-related sections for clinical, regulatory, and scientific documents (e.g., protocols, consent/assent, CRFs, statistical plans, clinical study reports/synopses, integrated safety summaries, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts).
- Collaborate on Company Core Safety Information (CCSI) and ensure implementation in Reference Safety Information (RSI), including Investigator Brochures, Company Core Data Sheet, and other labeling.
- Perform literature review for signal detection and aggregate reporting.
- Conduct signal detection/assessment: individual and aggregate analyses; interpret safety signals/trends; document and communicate safety assessments.
- Chair 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 listings).
- Contribute to Risk Management Plans (RMPs).
- Provide guidance on MedDRA and WHODrug coding for safety data.
- Ensure compliance with global PV regulations/guidelines (e.g., CIOMS, EMA, FDA, ICH) and SOPs; 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.
- Safety database knowledge (e.g., ARISg/ARGUS) and electronic data capture systems.
- MedDRA training and knowledge of MedDRA/WHO Drug coding dictionaries.
- PV audit experience and active participation in Regulatory Authority Inspections (preferred).
- Ability to manage multiple tasks with deadlines in a fast-paced environment.
- Knowledge of drug development process.
- Initiative and independence.
- Excellent written/oral communication, organization, and cross-functional teamwork.
- Computer literacy (Regulatory Databases; Microsoft Excel, PowerPoint, Word).
- Some national/international travel may be required.
Required/Preferred 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 other relevant specialty is a plus.
- Minimum 3 years Drug Safety/Pharmacovigilance experience OR 3+ years clinical development experience (other relevant experience may be considered).
Benefits (if part of the job description)
- Base pay range (US): $212,000.00 - $318,000.00.
- Discretionary annual cash bonus/incentive (depending on role) and discretionary equity grants.
- Medical, dental, vision insurance, 401k retirement savings plan, and flexible paid vacation.
Application instructions
- If you are a current Jazz employee: apply via the Internal Career site.