Building A Delegation Profile For The Qualified Person Responsible For Pharmacovigilance (QPPV)

The role of the Qualified Person Responsible for Pharmacovigilance (QPPV) is both broad and complex, requiring the delegation of tasks to ensure effective oversight and compliance. This article, originally published by the Pharmaceutical Information & Pharmacovigilance Association (PIPA), delves into the practicalities and necessities of delegating tasks within the QPPV's broad responsibilities, emphasizing the importance of strategic delegation to ensure efficient and effective pharmacovigilance systems.

Drawing insight from extensive experience, Cencora PharmaLex experts Susanne Becker and Dora Amene highlight how operational activities and subject matter expertise can be delegated to enhance the QPPV's oversight capabilities.

Key aspects such as goal setting, task definition, and communication frameworks are explored to illustrate how delegation can optimize workflows while maintaining compliance with EU pharmacovigilance guidelines. Through detailed examples and best practices, this article provides invaluable insights for QPPVs seeking to balance their extensive responsibilities with the need for specialized support and operational efficiency.

Reprint from μPIPELINE Issue 71, April 2024 ©Copyright Pharmaceutical Information and Pharmacovigilance Association. All rights reserved