Pharmacovigilance Manager

Job Summary

A company is looking for a Pharmacovigilance Manager, Aggregate & Trend Reports.

Key Responsibilities

• Generate PV trending data for human and veterinary products
• Prepare periodic adverse drug experience reports and aggregate safety reports
• Coordinate quarterly Data Safety Review Board meetings and maintain safety surveillance watchlist

Required Qualifications and Education

• Masters in Life Sciences, Biology, Biotech, Microbiology, or RN required; PharmD or PhD a plus
• Minimum of 5 years of experience in Pharmacovigilance, including preparation of PADERs
• Knowledge of safety databases (Argus, Argus Insight) is a plus
• Understanding of Worldwide/Health Authority regulations for adverse drug reporting
• Ability to assess adverse drug reactions and interpret data