Director, Medical Safety Scientist

If you are a current Jazz employee please apply via the Internal Career site.

Responsibilities:
- Lead cross-functional Medical Safety teams (SMTs) and drive safety strategy for responsible products/programs.
- Ensure safety governance processes/procedures are up to date for regulatory requirements and inspection readiness.
- Drive signal management (assessment and prioritization of safety concerns) and communicate with interdisciplinary teams.
- Evaluate safety information; identify need for labeling updates; produce clear evaluation documents.
- Coordinate aggregate safety reports (PBRERs, DSURs, PADERs) and author relevant sections.
- Author/guide risk management plans (RMPs) and provide strategic input into regulatory requests/responses.
- Deliver clinical safety input to clinical development; lead Medical Safety contributions to global regulatory submissions.
- Participate in/lead internal and joint safety surveillance meetings with licensing partners.
- Provide input into Safety Data Exchange Agreements/PV agreements; escalate issues to senior management.
- Mentor and train junior Medical Safety team members.

Minimum Requirements:
- 8+ years drug safety experience, including 5+ years in surveillance/risk management.
- Ability to search clinical safety and literature databases independently.
- 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 familiarity.
- Familiarity with MedDRA and safety databases; proficient with Windows; ability to learn new programs/databases.

Education:
- Degree (BS/BA/MSc/PhD) or professional life science qualification (e.g., nursing or pharmacy) or relevant scientific/technical discipline.

Benefits:
- Eligible for medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.