Pharmacovigilance Assistant

Job Summary

A company is looking for a Pharmacovigilance Assistant.

Key Responsibilities

• Prepares and submits reports via approved databases, such as E-Submitter or PV Works
• Submits anti-microbial reports to the FDA for company pharmaceutical products
• Compiles and organizes reporting metric data for review and contributes to special project work as assigned

Required Qualifications

• Bachelor's degree in biology, animal science, pharmacy, business, or related science
• A minimum of 1 year of experience in the regulatory field
• Experience with PV Works and Microsoft Office Suite, specifically Excel
• Knowledge of 21CFR514.80 or 21CFR514.3 regulations is preferred
• Candidates must be located in the EST time zone