The QPPV is to be a natural person, being defined (Guidelines on Good Pharmacovigilance Practices (GVP) I.C.1.3, footnote) as a ‘real human being’. This is rather denoting. Really human …
Though it is the marketing authorisation holder’s responsibility to manage the Pharmacovigilance (PV) system or to create a Pharmacovigilance System Master File (PSMF), the QPPV is indeed impressive. He/she has:
- Sufficient authority,
- Access to information regarding compliance and Adverse Drug Reactions (ADRs),
- Information about mergers, acquisitions, distributors,
- Adequate theoretical and practical knowledge,
- Skills for the management of PV systems,
- Expertise (or access to expertise) in relevant areas,
- His/her residence and fields of operation in the EEA,
- A back-up (formerly deputy),
- Company-specific training.
This only describes what the QPPV has. The responsibilities are described with many more words. Though surprising to some, this includes e.g. involvement in the signing of post authorisation safety studies (PASSs) or information about their results. And there is only ONE QPPV for one PV system (even if multiple authorisation holders are covered by it).
The first good news is that much of what is needed to become a good QPPV may be learned. The second good news is that the QPPV may also be outsourced (GVP I.C1.5.) – given certain conditions.
Basically, the above similarly applies to the Graduated Plan Officer (GPO) in Germany. However, this function is not dependent on a marketing authorisation, but is mandatory for every pharmaceutical entrepreneur who places finished medicinal product on the market in Germany. Particularities:
- The GPO has to be reliable (criminal record certificate),
- is also responsible for technical complaints,
- is (dependent on the local supervising authority) also required for clinical research and
- is personally liable.