Director, Medical Safety Scientist
Jazz Pharmaceuticals
August 10, 2026
Remote friendly (Philadelphia, PA)
United States
Medical Affairs
Director, Medical Safety (Scientist)
Responsibilities:
- Lead cross-functional safety management teams (SMTs) and drive safety strategy for responsible product/program.
- Ensure safety governance processes/procedures are up to date for regulatory requirements and inspection readiness.
- Drive signal management using available methodologies, recommending assessment and prioritization of safety concerns.
- Communicate with interdisciplinary teams on ongoing signal evaluation.
- Evaluate safety information to meet internal/external requirements, including identifying labeling updates; produce accurate evaluation documents with clear conclusions.
- Coordinate aggregate safety reports (PBRERs, DSURs, PADERs) and author relevant sections.
- Author or provide guidance for risk management plans (RMPs).
- Provide strategic input into regulatory requests/responses.
- Deliver clinical safety input into clinical development programs.
- Lead medical safety contributions to global regulatory submissions for new products/formulations/indications.
- Participate in and/or lead internal and joint safety surveillance meetings with licensing partners as needed.
- Provide medical safety input into Safety Data Exchange Agreements and/or other PV agreements.
- Escalate issues/concerns to senior management timely.
- Mentor and train junior Medical Safety team members.
Minimum Requirements:
- 8+ years drug safety experience, including 5+ years in surveillance/risk management.
- Ability to independently search clinical safety and literature databases.
- Expert knowledge of pharmacovigilance regulations (aggregate reports, RMPs, signal management).
- Excellent medical writing; proven ability to lead interdisciplinary teams.
- In-depth medical/drug terminology knowledge and clinical development process knowledge.
- Familiarity with MedDRA and safety databases; proficient with Windows; ability to learn new programs/databases.
Education:
- Degree (BS/BA/MSc/PhD) or professional qualification in a life science field or relevant scientific/technical discipline.
Benefits:
- Eligible for medical, dental, and vision insurance; retirement savings plan; flexible paid vacation.
Application instructions:
- If you are a current Jazz employee, apply via the Internal Career site.
Responsibilities:
- Lead cross-functional safety management teams (SMTs) and drive safety strategy for responsible product/program.
- Ensure safety governance processes/procedures are up to date for regulatory requirements and inspection readiness.
- Drive signal management using available methodologies, recommending assessment and prioritization of safety concerns.
- Communicate with interdisciplinary teams on ongoing signal evaluation.
- Evaluate safety information to meet internal/external requirements, including identifying labeling updates; produce accurate evaluation documents with clear conclusions.
- Coordinate aggregate safety reports (PBRERs, DSURs, PADERs) and author relevant sections.
- Author or provide guidance for risk management plans (RMPs).
- Provide strategic input into regulatory requests/responses.
- Deliver clinical safety input into clinical development programs.
- Lead medical safety contributions to global regulatory submissions for new products/formulations/indications.
- Participate in and/or lead internal and joint safety surveillance meetings with licensing partners as needed.
- Provide medical safety input into Safety Data Exchange Agreements and/or other PV agreements.
- Escalate issues/concerns to senior management timely.
- Mentor and train junior Medical Safety team members.
Minimum Requirements:
- 8+ years drug safety experience, including 5+ years in surveillance/risk management.
- Ability to independently search clinical safety and literature databases.
- Expert knowledge of pharmacovigilance regulations (aggregate reports, RMPs, signal management).
- Excellent medical writing; proven ability to lead interdisciplinary teams.
- In-depth medical/drug terminology knowledge and clinical development process knowledge.
- Familiarity with MedDRA and safety databases; proficient with Windows; ability to learn new programs/databases.
Education:
- Degree (BS/BA/MSc/PhD) or professional qualification in a life science field or relevant scientific/technical discipline.
Benefits:
- Eligible for medical, dental, and vision insurance; retirement savings plan; flexible paid vacation.
Application instructions:
- If you are a current Jazz employee, apply via the Internal Career site.