Provision of EEA Qualified Person for Pharmacovigilance (EEA QPPV)

All Market Authorisation Holders are required to have a Qualified Person responsible for pharmacovigilance in the EEA.

The QPPV must reside and operate in the EU, be experienced in all aspects of pharmacovigilance.
Pharmafile PV QPPVs have extensive knowledge and experience of the industry and reside in more than one EU member state.

Pharmafile PV can offer experienced persons to act as the QPPV or deputy, providing your company with support in order to meet the necessary legal requirements, from submission of a Market Authorisation and throughout the product lifetime.
Our experienced QPPVs can work within your PV system which has been outsourced to Pharmafile PV.

Pharmafile PV can audit your existing QPPV and PV system and identify gaps in oversight and advice on optimal arrangements, recommending corrective actions to ensure your PV system meets the requirements of the legislation.

For more information please contact us at enquiries@pharmafile.ie