QUALIFIED PERSON FOR PHARMACOVIGILANCE (QPPV)

The Qualified Person for Pharmacovigilance (QPPV) is an individual personally responsible for a Pharmaceutical company/Marketing Authorization Holders adherence to the legal requirements for drug safety activities. These activities include safety surveillance, reporting, quality system, documentation, training and benefit/risk assessments. For the EU QPPV the requirements are clarified in the Commission Pharmacovigilance implementing regulation 520-2012 as well as the Good Vigilance Practice guidelines.

It is important to understand the role of the QPPV as being responsible for the legally compliant conduct of the entire company in the European Union and at the same time it is the responsibility for the QPPV to ensure that the company internally cooperate efficiently in the many functions that need to work together to be successful – legal, regulatory, development, quality, medical affairs, sales, pharmacovigilance, local operating companies to mention some of them.