Qualified Person for Pharmacovigilance (QPPV) / Graduated Plan Officer

The Qualified Person for Pharmacovigilance (EU/EEA-QPPV) and the German Officer of the Graduated Plan (Stufenplanbeauftragter, GPO) play a central role in the Pharmacovigilance system.

Their tasks and responsibilities are described in corresponding laws and regulations. According to current GVP modules and German Drug Law (AMG) the QPPV / Officer of the Graduated Plan are the persons in charge for Pharmacovigilance in your enterprise. Responsibilities include:

  • analysis, assessment and response to drug safety risks,
  • activities related to detection, assessment, understanding and prevention of adverse drug reactions or other product associated problems,
  • risk management,
  • internal audits of the Pharmacovigilance system at regular intervals and implementation of necessary changes,
  • provision of medicinal product information,
  • safety measurements,
  • reporting to concerned authorities.
  • GPO: Quality issues related to drug safety risks.

If you are looking for a QPPV respectively GPO or if you just look for competent support in this matter please feel free to contact us.

We will give you all the strategic advice and operative support you require.