Senior Safety Specialist
4 days ago
We are seeking a highly experienced Pharmacovigilance (PV) expert to lead our safety team. As a PV Senior Safety Scientist, you will oversee and manage safety signal activities, aggregate reports, and respond to safety questions from internal and external stakeholders.
Key Responsibilities:
- Lead signal management process for assigned products, including signal detection, tracking, documentation, and risk evaluation.
- Respond to regulatory authorities' safety questions and collaborate with Global Safety Officers on clinical trial activities.
- Manage aggregate report strategy, review, and finalization for PSURs, DSURs, RMPs, and other safety reports.
Requirements:
- Bachelor's or advanced degree in biologic or natural science, health case discipline, or related field.
- Proven experience in pharmacovigilance, aggregate safety reports, and safety signal management.
- Strong problem-solving capabilities and excellent communication skills.
Estimated Salary: $120,000 - $180,000 per year
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