When a company submits an application for permission to bring a medicinal product onto the market, the company submits a description of its system for monitoring the safety of the product in actual use (a pharmacovigilance system) and proof that the services of a QPPV are in place.
[1] "The holder of an authorisation for a medicinal product for human use granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance."
Per GVP, the QPPV is responsible for the establishment and maintenance of the marketing authorisation holder's pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements.
Detailed information on the role and responsibilities of the QPPV, and guidance for a Marketing Authorisation Holder on how to adequately support the QPPV are specified in Guideline on good pharmacovigilance practices (GVP; Module I – Pharmacovigilance systems and their quality systems).
"[2] At a minimum the QPPV should be appropriately qualified, with documented experience in all aspects of pharmacovigilance in order to fulfil the responsibilities and tasks of the post.