Qualified Person for Pharmacovigilance (QPPV)

The Qualified Person for Pharmacovigilance (EU/EEA-QPPV) and the German Officer of the Graduated Plan (Stufenplanbeauftragter) 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. The QPPV is i.e. responsible for

  • 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.

If you are looking for a QPPV, or deputy for your QPPV or if you as QPPV strongly look for competent support please feel free to contact us.

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

Audits

Pharmaceutical companies are regulatory obliged to ensure internal and compliance of contracted partner through audits >>

Processes - SOPs

PV processes should comply with regulatory requirements (such as GVP Modules) through corresponding conception, design and implementation >>