Medical Director, Medical Safety
Jazz Pharmaceuticals
7 months ago
Remote friendly (Philadelphia, PA)
United States
Medical Affairs
Brief Description
- The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle.
Responsibilities
- Lead preparation and review of safety-related sections for assigned product/s (e.g., protocols, informed 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/journal articles).
- Serve as safety representative on a Global Regulatory Team and Core Development Team.
- Interface with the REMS team to optimize risk management from a PV perspective.
- Support creation/maintenance of Company Core Safety Information (CCSI) and ensure implementation in Reference Safety Information (RSI) (e.g., Investigator Brochures, CCDS, national labels, and associated product labeling).
- Review medical/scientific literature to support signal detection and aggregate reporting.
- Support signal detection/assessment: identification, evaluation, validation; conduct individual and aggregate analyses; interpret safety signals/trends; document and communicate safety assessments with CRSO and PV management.
- Participate in or lead Safety Management Teams (SMT) for assigned products.
- Contribute to pre- and post-marketing aggregate safety reporting (IND Annual Reports, 6-monthly SUSAR line listings) and consistent communication across regulatory safety documents.
- Contribute to Risk Management Plans (RMPs) (risk identification, risk minimization, and effectiveness measures).
- Provide guidance on adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data.
- Demonstrate knowledge of global PV regulations/guidelines, SOPs, and quality standards; keep abreast of PV/safety updates.
- Provide safety expertise to due diligence activities (if/as needed).
Minimum Requirements
- 2–5 years of Clinical Development, Medical Affairs, or Drug Safety/Pharmacovigilance experience (other relevant medical affairs may be considered).
Required Skills/Abilities
- Excellent knowledge of the drug development process.
- High initiative and independence.
- Excellent written and oral communication; resourcefulness and personal organization; demonstrated cross-functional teamwork.
- Computer literacy including proficiency with external regulatory databases and Microsoft Excel, PowerPoint, and Word.
- Ability to manage multiple tasks with deadlines in a fast-paced environment.
- Some national/international travel may be required.
Preferred Skills
- Working knowledge of safety databases (e.g., ARISg, ARGUS) and electronic data capture systems.
- MedDRA training and working knowledge of MedDRA and WHO Drug coding dictionaries.
- Exposure/working relationship with FDA, EMA, and other regulatory authorities.
Education/Licenses
- MD required; medical licensure in at least one region preferred.
Benefits (US)
- Eligible for medical, dental, and vision insurance; 401(k) retirement savings plan; and flexible paid vacation.
- The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle.
Responsibilities
- Lead preparation and review of safety-related sections for assigned product/s (e.g., protocols, informed 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/journal articles).
- Serve as safety representative on a Global Regulatory Team and Core Development Team.
- Interface with the REMS team to optimize risk management from a PV perspective.
- Support creation/maintenance of Company Core Safety Information (CCSI) and ensure implementation in Reference Safety Information (RSI) (e.g., Investigator Brochures, CCDS, national labels, and associated product labeling).
- Review medical/scientific literature to support signal detection and aggregate reporting.
- Support signal detection/assessment: identification, evaluation, validation; conduct individual and aggregate analyses; interpret safety signals/trends; document and communicate safety assessments with CRSO and PV management.
- Participate in or lead Safety Management Teams (SMT) for assigned products.
- Contribute to pre- and post-marketing aggregate safety reporting (IND Annual Reports, 6-monthly SUSAR line listings) and consistent communication across regulatory safety documents.
- Contribute to Risk Management Plans (RMPs) (risk identification, risk minimization, and effectiveness measures).
- Provide guidance on adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data.
- Demonstrate knowledge of global PV regulations/guidelines, SOPs, and quality standards; keep abreast of PV/safety updates.
- Provide safety expertise to due diligence activities (if/as needed).
Minimum Requirements
- 2–5 years of Clinical Development, Medical Affairs, or Drug Safety/Pharmacovigilance experience (other relevant medical affairs may be considered).
Required Skills/Abilities
- Excellent knowledge of the drug development process.
- High initiative and independence.
- Excellent written and oral communication; resourcefulness and personal organization; demonstrated cross-functional teamwork.
- Computer literacy including proficiency with external regulatory databases and Microsoft Excel, PowerPoint, and Word.
- Ability to manage multiple tasks with deadlines in a fast-paced environment.
- Some national/international travel may be required.
Preferred Skills
- Working knowledge of safety databases (e.g., ARISg, ARGUS) and electronic data capture systems.
- MedDRA training and working knowledge of MedDRA and WHO Drug coding dictionaries.
- Exposure/working relationship with FDA, EMA, and other regulatory authorities.
Education/Licenses
- MD required; medical licensure in at least one region preferred.
Benefits (US)
- Eligible for medical, dental, and vision insurance; 401(k) retirement savings plan; and flexible paid vacation.