Qualified Person for Pharmacovigilance
Medicinal products cannot be marketed in the EEA without a Qualified Person for Pharmacovigilance (QPPV). The QPPV is responsible for over-seeing the core elements of pharmacovigilance for a pharmaceutical company and fulfill certain crucial roles within the pharmacovigilance system. The QPPV will be personally addressed regarding the safety of the medicinal products, and must reside in the European Union.
There are 3 key functions the QPPV has to fulfill:
- Establishing, maintaining and overseeing the pharmaceutical company’s pharmacovigilance system
- Overseeing the safety profiles of all the company’s marketed products and any emerging safety concerns
- Acting as a single contact point for the regulatory authorities on a 24-hour basis and for pharmacovigilance inspections