Freelance PV Auditor (USA and Canada)

About the role

Ergomed is recruiting a freelance Pharmacovigilance (PV) Auditor to cover audits across the USA and Canada. Both full-time and part-time arrangements (0.6+ FTE) are considered. The work involves planning, preparing, conducting, reporting and following up on PV audits, including CAPA plans.

Key responsibilities

• Plan, prepare, conduct, report and follow up on various types of Pharmacovigilance audits according to expected quality and timelines
• Execute audits based on a thorough understanding of regulatory requirements and Good Pharmacovigilance Practice (GVP)
• Carry out GVP quality assurance projects on behalf of client companies in the pharmaceutical and biotechnology industry

Required profile

• Experience conducting and leading internal and external PV audits for a variety of stakeholders
• Expert knowledge of national and international pharmacovigilance legislation and guidelines
• Ability to manage projects and ensure deliverables are provided on time
• Ability to identify issues and offer practical solutions
• Bachelor's degree in Life Sciences preferred
• Willingness to travel up to 40% and to conduct remote audits