Global Drug Safety Lead
3 days ago
Company Overview
Jazz Pharmaceuticals plc is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases. Our purpose is to innovate to transform the lives of patients and their families.
Job Summary
We are seeking an experienced Senior Manager, Medical Safety to join our Global Drug Safety & Pharmacovigilance department. This role will involve managing signals, producing aggregate safety reports, and providing high-level scientific expertise in safety evaluation and risk management.
Responsibilities
- Manage signals and produce aggregate safety reports (PBRERs, DSURs, PADERs)
- Collaborate with Medical Safety Physicians to drive signal management/clinical surveillance process
- Provide high-level scientific expertise in safety evaluation and risk management
Requirements
- 5+ years of experience in Pharmacovigilance (PV), including 3+ years in surveillance and/or risk management PV functions.
- Advanced knowledge of PV regulations regarding aggregate safety reports, signal management, and risk management.
- Excellent medical writing skills and ability to lead interdisciplinary teams.
Salary Range
$120,000 - $150,000 per annum.
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