What does delegation mean for the qualified person responsible for pharmacovigilance?

Abstract

In the EU/EEA, the qualifi ed person for pharmacovigilance (QPPV) is personally accountable for the pharmacovigilance quality system of a marketing authorisation holder (MAH). This has resulted in a long list of tasks, and implementation of these, which require oversight and delegation. Regardless of how these responsibilities appear in the legislation, what they mean in reality has neither been defi ned nor agreed within the pharmaceutical sector. This article proposes how a QPPV should implement oversight and approach delegation. Training to fulfi l these responsibilities is required as part of the toolkit for the QPPV, and the management of the MAH is obliged by the legislation to provide all necessary support to enable the QPPV to discharge his/her responsibilities.