Pharmacovigilance Lead Auditor

3 days ago


Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

About the Role

We are seeking a seasoned Pharmacovigilance Lead Auditor to join our Global Quality team at ALK-Abello. As a key member of our quality assurance function, you will be responsible for conducting internal and external audits, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities

  • Performing PV audits as Lead Auditor, both independently and in collaboration with other PV and GDP Lead Auditors in ALK-Abello.
  • Planning, execution, reporting, and CAPA follow-up.
  • Supplier Management, qualification of external collaborators, service providers, and distributors.

Your Profile

We are looking for an experienced professional with a strong background in pharmacovigilance and quality management. The ideal candidate will have:

  • Experience as Lead Auditor within PV, performing internal audits and audits of external collaborators (distributors and service providers), with the ability to start directly in a PV Lead Auditor position.
  • B.Sc. / M.Sc. in Health Science with 5+ years of experience within pharmacovigilance regulated areas, including experience with quality management systems and tools.
  • Experience with audits within other GxP areas is an advantage.

What We Offer

ALK-Abello offers a competitive salary of approximately $85,000 per year, plus benefits and opportunities for career growth and development. Our company values include professionalism, integrity, and open-mindedness, and we strive to create a dynamic and collaborative work environment.

How to Apply

To apply for this exciting opportunity, please submit your CV and a short letter of motivation by [Application Deadline]. We look forward to hearing from you



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