Pharmacovigilance Outsourcing

QPPV – Qualified Person for Pharmacovigilance (EU QPPV)

PrimeVigilance offers experienced EU QPPVs and Deputy EU QPPVs with extensive knowledge and experience of the industry.

The marketing authorization holder (MAH) is legally required to have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance in the EU (EU QPPV).

EU QPPV is responsible for the fulfillment of key PV functions:

  1. Establishing and maintenance of the MAH’s pharmacovigilance (PV) system and therefore shall have sufficient authority to influence the performance of the quality system and the PV activities and to promote, maintain and improve compliance with the legal requirements
  2. Having an overview of medicinal product safety profiles and any emerging safety concerns
  3. Acting as a single PV contact point for the EMA and EU Competent Authorities on a 24-hour basis, and the contact point for inspections
  4. Ensuring and verifying that the information contained in the Pharmacovigilance System Master File (PSMF) is an accurate and up-to-date reflection of that PV system

EU QPPV must reside and operate in the EU, Norway, Iceland, or Liechtenstein. EU QPPV shall be appropriately qualified, shall be at the MAH´s disposal permanently and continuously, and must be experienced in all aspects of PV.

Why Outsource Your EU QPPV?

Recruiting and appointing your EU QPPV can consume a great deal of your time and resources. Our support allows for a greater economy without sacrificing quality.

PrimeVigilance EU QPPVs have extensive knowledge and experience of the industry and reside in various EU member states.

Our experienced EU QPPVs can work within your PV system which has been outsourced to PrimeVigilance.

PrimeVigilance can audit your existing EU QPPV and PV system and identify gaps in oversight and advice on optimal arrangements, recommending corrective actions to ensure your PV system meets the requirements of the legislation.

Just one of the pharmacovigilance services from PrimeVigilance

For more information contact PrimeVigilance today

References
1European Medicines Agency. 22 June 2012 EMA/541760/2011. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems.

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