EEA Qualified Person for Pharmacovigilance
Marketing Authorisation Holders (MAH) in the European Economic Area (EEA) must have permanently and continuously at their disposal a Qualified Person Responsible for Pharmacovigilance (QPPV). The QPPV is personally responsible for the establishment and maintenance of the MAH’s pharmacovigilance system.
Choosing to use a contract QPPV is an important decision. The relationship between a MAH and its QPPV needs to be one of trust, cooperation and flexibility. Mapi has a team of experienced QPPVs located in the UK with a proven track record of successful MAH-QPPV relationships in a wide variety of organisational systems. Our QPPVs have significant experience of regulatory inspections. Our QPPVs are:
- Focused on patient safety;
- Available 24 hours a day, 7 days a week;
- Experienced pharmacovigilance personnel with good communication skills;
- Up-to-date with legislation within the EEA and on a wider scale;
- Pragmatic in their approach;
- Adapt at pharmacovigilance system development;
- Have access to a team of experienced safety physicians;
- Experienced at overseeing all aspects of a pharmacovigilance system, including its Quality Management System;
- Practiced at managing safety profiles of a wide diversity of products.