Pharmacovigilance Operations Specialist

Job Summary

A company is looking for a PV Operations Specialist to support drug safety and pharmacovigilance operations.

Key Responsibilities

• Participate in clinical study team meetings to provide pharmacovigilance support
• Liaison with PV Operations and other teams on study deliverables and vendor oversight
• Support audit preparations and monitor quality of vendor processing for safety reports

Required Qualifications

• Bachelor's degree in nursing, pharmacy, or a related health care profession or life sciences
• Minimum of 3 years of experience in Drug Safety/Pharmacovigilance in a pharmaceutical setting
• Experience with CROs and vendor relationship management preferred
• Knowledge of ICH Good Pharmacovigilance Practices and FDA/EU legislation
• Experience with Argus database management is a plus