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All Pharmacovigilance questions

Question 7 of 20 Fundamentals Concept

What does the EU qualified person for pharmacovigilance do?

Short answer

The qualified person responsible for pharmacovigilance (QPPV) is the named individual a marketing authorisation holder must have permanently and continuously at its disposal in the EU. The QPPV oversees the whole pharmacovigilance system, its quality and its compliance, and is the contact point for regulators. The US has no equivalent legal role.

Why

GVP Module I sets out the QPPV's place in the EU system. Every marketing authorisation holder must have one, who resides and operates in the EU, with a back-up for absences. The QPPV is responsible for establishing and maintaining the pharmacovigilance system, having oversight of the safety profile of the products and any emerging safety concerns, and acting as the single point of contact for competent authorities around the clock.

That means knowing the risk management plans, the periodic safety update reports, the signal management process and the performance of case processing, even when work is outsourced. The QPPV also needs the authority to change the system when it is not working. The pharmacovigilance system master file describes the system and names the QPPV.

In the US, FDA places duties on the applicant through regulations such as 21 CFR 314.80 but does not require a named individual with this role. Many global companies still appoint a head of safety who plays a similar part for FDA matters.

A strong answer covers

  • Legal requirement for every EU marketing authorisation holder
  • Resides and operates in the EU, with a back-up
  • Oversight of system, safety profiles and compliance
  • Single contact point for authorities
  • No equivalent named role in US law

Common mistakes

  • Thinking the QPPV personally processes every case.
  • Assuming outsourcing pharmacovigilance moves the QPPV's oversight to the vendor.
  • Claiming FDA requires a QPPV.