About The Position

ADAMAS Consulting is looking for a PV Auditor on a freelance basis to cover audits across Europe. Both full and part time (0.6+ FTE) will be considered. This role involves planning, preparation, conduct, reporting, and follow-up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines. The auditor will execute audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP), and perform GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.

Requirements

  • Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders
  • Expert knowledge of national and international Pharmacovigilance legislation and guidelines
  • Proficient in managing projects and ensuring deliverables are provided timeously
  • Ability to identify issues and offer solutions in a pragmatic way
  • Bachelor’s Degree in Life Sciences preferred
  • Up to 40% travel and ability to conduct remote audits

Responsibilities

  • Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines
  • Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP)
  • Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
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