Medical Director, Medical Safety
Jazz Pharmaceuticals
6 months ago
Remote friendly (Palo Alto, CA)
United States
Medical Affairs
Brief Description
- The Global Safety Physician is 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 the 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 summaries of safety, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts/journal articles).
- Serve as the safety representative for Global Regulatory and Core Development teams.
- Interface with the REMS team to optimize risk management of assigned products from a PV perspective.
- Support creation/maintenance of Company Core Safety Information (CCSI) and ensure CCSI implementation in Reference Safety Information (RSI) including Investigator Brochures, CCDS, national labels, and related product labeling.
- Review medical/scientific literature to support signal detection and aggregate reporting.
- Support signal detection activities: identification, evaluation, validation; individual and aggregate data analyses; interpret safety signals/trends; document and communicate safety assessments (written and verbal) with CRSO and PV management.
- Participate in or lead a Safety Management Team (SMT) for assigned products.
- Contribute to pre- and post-marketing aggregate safety reports (IND Annual Reports; 6-monthly SUSARs line listings) and ensure consistent safety communications across regulatory documents.
- Contribute to Risk Management Plans (RMPs) including risk identification and appropriate risk minimization/effectiveness measures.
- Provide guidance on MedDRA and WHO Drug coding for clinical and postmarketing safety data.
- Stay current on global PV/safety regulations and guidance; provide safety expertise to due diligence activities as needed.
Minimum Requirements
- 2–5 years of experience in Clinical Development, Medical Affairs, or Drug Safety/Pharmacovigilance (other relevant medical affairs experience may be considered).
- Excellent knowledge of the drug development process.
- Initiative and independence; excellent written/oral communication; resourcefulness and organization; demonstrated cross-functional teamwork.
- Computer literacy: external Regulatory Databases; Microsoft Excel, PowerPoint, and Word.
- Some national/international travel may be required.
Leadership / Additional Qualifications (Preferred)
- Working knowledge of international regulations and Good Clinical and Pharmacovigilance practices (GCP, GVP).
- Exposure to working relationship with FDA/EMA and other regulatory authorities preferred.
- Working knowledge of safety databases (e.g., ARISg, ARGUS) and electronic data capture systems a plus.
- MedDRA training and working knowledge of MedDRA/WHO Drug coding dictionaries a plus.
Education and Licenses
- MD required; medical licensure in at least one region preferred.
- Clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus.
Benefits (US, explicitly mentioned)
- Medical, dental and vision insurance; 401k retirement savings plan; flexible paid vacation.
Application instructions (as stated)
- If you are a current Jazz employee, please apply via the Internal Career site.
- The Global Safety Physician is 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 the 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 summaries of safety, NDA/BLA, MAA, CTD submissions, regulatory responses, IRB/EC requests, briefing books, manuscripts/journal articles).
- Serve as the safety representative for Global Regulatory and Core Development teams.
- Interface with the REMS team to optimize risk management of assigned products from a PV perspective.
- Support creation/maintenance of Company Core Safety Information (CCSI) and ensure CCSI implementation in Reference Safety Information (RSI) including Investigator Brochures, CCDS, national labels, and related product labeling.
- Review medical/scientific literature to support signal detection and aggregate reporting.
- Support signal detection activities: identification, evaluation, validation; individual and aggregate data analyses; interpret safety signals/trends; document and communicate safety assessments (written and verbal) with CRSO and PV management.
- Participate in or lead a Safety Management Team (SMT) for assigned products.
- Contribute to pre- and post-marketing aggregate safety reports (IND Annual Reports; 6-monthly SUSARs line listings) and ensure consistent safety communications across regulatory documents.
- Contribute to Risk Management Plans (RMPs) including risk identification and appropriate risk minimization/effectiveness measures.
- Provide guidance on MedDRA and WHO Drug coding for clinical and postmarketing safety data.
- Stay current on global PV/safety regulations and guidance; provide safety expertise to due diligence activities as needed.
Minimum Requirements
- 2–5 years of experience in Clinical Development, Medical Affairs, or Drug Safety/Pharmacovigilance (other relevant medical affairs experience may be considered).
- Excellent knowledge of the drug development process.
- Initiative and independence; excellent written/oral communication; resourcefulness and organization; demonstrated cross-functional teamwork.
- Computer literacy: external Regulatory Databases; Microsoft Excel, PowerPoint, and Word.
- Some national/international travel may be required.
Leadership / Additional Qualifications (Preferred)
- Working knowledge of international regulations and Good Clinical and Pharmacovigilance practices (GCP, GVP).
- Exposure to working relationship with FDA/EMA and other regulatory authorities preferred.
- Working knowledge of safety databases (e.g., ARISg, ARGUS) and electronic data capture systems a plus.
- MedDRA training and working knowledge of MedDRA/WHO Drug coding dictionaries a plus.
Education and Licenses
- MD required; medical licensure in at least one region preferred.
- Clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus.
Benefits (US, explicitly mentioned)
- Medical, dental and vision insurance; 401k retirement savings plan; flexible paid vacation.
Application instructions (as stated)
- If you are a current Jazz employee, please apply via the Internal Career site.