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:

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