Pharmacovigilance Safety Specialist
Job Summary
Managing individual case safety reports, the full-time Pharmacovigilance Safety Specialist will perform case-level assessments, compose medical narratives, and ensure compliance with regulatory reporting criteria, while working in a hybrid environment.
Key responsibilities
- Process adverse event cases, including coding with MedDRA and assessing seriousness and expectedness
- Conduct case follow-up activities and create detailed case narratives
- Support training material development and provide client notifications as needed
Required qualifications
- Bachelor's degree in life sciences is required
- Two years of related work experience is necessary
- Basic knowledge of Pharmacovigilance is essential
- Preferred qualifications include an advanced degree, RN, RPh, PharmD, or equivalent
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