Medical Safety Professional
1 week ago
The Senior Manager, Medical Safety role is a critical position within the Global Drug Safety & Pharmacovigilance department. As a key member of the Medical Safety team, you will work closely with Medical Safety Physicians to manage signals, produce aggregate safety reports, and provide high-level scientific expertise in safety evaluation and risk management.
Responsibilities
- Coordinate the production of aggregate safety reports (PBRERs, DSURs, PADERs) and author relevant safety sections.
- Drive signal management/clinical surveillance process using available methodologies, making recommendations for assessment and prioritization of safety concerns.
- Ensure available safety information is evaluated to meet internal and external requirements, identifying labeling updates as needed.
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
This role offers a competitive salary of $120,000 - $150,000 per annum, depending on experience.
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