Medical Director, Medical Safety
Jazz Pharmaceuticals
6 months ago
Remote friendly (Carlsbad, CA)
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.
- Supports major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation, and risk management activities.
- Interfaces cross-functionally (all levels) and with external Regulatory Authorities; partners with PV management to prepare safety reports and communicate changes in the product risk profile.
Responsibilities (Essential Functions)
- Lead preparation and review of safety-related sections for assigned products, including review of protocols, informed consent/assent forms, CRFs, statistical plans, clinical study reports/synopses, integrated summaries of safety, NDA/BLA, MAA, CTD submissions, regulatory agency responses, IRB/EC requests, briefing books, and manuscripts/journal articles.
- Serve as safety representative for a Global Regulatory Team and Core Development Team.
- Interface with REMS team to optimize PV risk management for assigned products.
- 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 other labeling.
- Review medical/scientific literature relevant to signal detection and aggregate reporting.
- Support signal detection: signal identification, evaluation, validation; individual and aggregate analyses; interpret safety signals/trends; document and communicate safety assessments with CRSO and PV management.
- Participate in or lead a Safety Management Team (SMT).
- Contribute to pre- and post-marketing aggregate safety reports (IND Annual Reports) and 6-monthly SUSAR line listing reports; ensure consistent communication across regulatory safety documents.
- Contribute to Risk Management Plans (RMPs) for assigned products.
- Provide guidance for MedDRA and WHO Drug coding for clinical and postmarketing safety data.
- Demonstrate knowledge of global PV regulations/guidelines (e.g., CIOMS, EMA, FDA, ICH), SOPs, and quality standards; keep abreast of new PV/safety guidance.
- Provide safety expertise to due diligence activities, as needed.
Minimum Requirements
- 2–5 years of Clinical Development, Medical Affairs, or Drug Safety/Pharmacovigilance experience (other relevant medical affairs experience may be considered).
- Excellent knowledge of drug development process.
- High initiative and independence.
- Excellent written/oral communication, resourcefulness, organization, and cross-functional teamwork.
- Proficiency with external regulatory databases and Microsoft Excel, PowerPoint, and Word.
- Some national/international travel may be required.
Leadership/Additional Preferences
- Understanding of target product profile; clinical designs and/or global PV regulatory environment; knowledge of GCP/GVP.
- Exposure to FDA/EMA/regulatory authority relationships (preferred).
- Working knowledge of safety databases (ARISg, ARGUS) and electronic data capture systems (plus).
- MedDRA training and working knowledge of MedDRA/WHO Drug coding dictionaries (plus).
Education/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 (plus).
Benefits (US candidates only; explicitly stated)
- Eligible for medical, dental, and vision insurance; 401(k) retirement savings plan; and flexible paid vacation.
Application Instructions (as stated)
- If a current Jazz employee, apply via the Internal Career site.
- 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.
- Supports major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation, and risk management activities.
- Interfaces cross-functionally (all levels) and with external Regulatory Authorities; partners with PV management to prepare safety reports and communicate changes in the product risk profile.
Responsibilities (Essential Functions)
- Lead preparation and review of safety-related sections for assigned products, including review of protocols, informed consent/assent forms, CRFs, statistical plans, clinical study reports/synopses, integrated summaries of safety, NDA/BLA, MAA, CTD submissions, regulatory agency responses, IRB/EC requests, briefing books, and manuscripts/journal articles.
- Serve as safety representative for a Global Regulatory Team and Core Development Team.
- Interface with REMS team to optimize PV risk management for assigned products.
- 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 other labeling.
- Review medical/scientific literature relevant to signal detection and aggregate reporting.
- Support signal detection: signal identification, evaluation, validation; individual and aggregate analyses; interpret safety signals/trends; document and communicate safety assessments with CRSO and PV management.
- Participate in or lead a Safety Management Team (SMT).
- Contribute to pre- and post-marketing aggregate safety reports (IND Annual Reports) and 6-monthly SUSAR line listing reports; ensure consistent communication across regulatory safety documents.
- Contribute to Risk Management Plans (RMPs) for assigned products.
- Provide guidance for MedDRA and WHO Drug coding for clinical and postmarketing safety data.
- Demonstrate knowledge of global PV regulations/guidelines (e.g., CIOMS, EMA, FDA, ICH), SOPs, and quality standards; keep abreast of new PV/safety guidance.
- Provide safety expertise to due diligence activities, as needed.
Minimum Requirements
- 2–5 years of Clinical Development, Medical Affairs, or Drug Safety/Pharmacovigilance experience (other relevant medical affairs experience may be considered).
- Excellent knowledge of drug development process.
- High initiative and independence.
- Excellent written/oral communication, resourcefulness, organization, and cross-functional teamwork.
- Proficiency with external regulatory databases and Microsoft Excel, PowerPoint, and Word.
- Some national/international travel may be required.
Leadership/Additional Preferences
- Understanding of target product profile; clinical designs and/or global PV regulatory environment; knowledge of GCP/GVP.
- Exposure to FDA/EMA/regulatory authority relationships (preferred).
- Working knowledge of safety databases (ARISg, ARGUS) and electronic data capture systems (plus).
- MedDRA training and working knowledge of MedDRA/WHO Drug coding dictionaries (plus).
Education/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 (plus).
Benefits (US candidates only; explicitly stated)
- Eligible for medical, dental, and vision insurance; 401(k) retirement savings plan; and flexible paid vacation.
Application Instructions (as stated)
- If a current Jazz employee, apply via the Internal Career site.