The roles and responsibilities of an EEA Qualified Person for Pharmacovigilance are based on the current Directive 2001/83/EC and Vol 9A of the Rules Governing Medicinal Products in the European Union. Vol 9A states that the QPPV is responsible for the “overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations within the EU.”
The QPPV has three main areas of responsibility:
- To ensure the Marketing Authorisation holder has an appropriate pharmacovigilance system in place
- To have an overview of a safety profile for the products for which the company holds a Marketing Authorisation
- To be the point of contact with the competent authorities
A QPPV has a central role focused on ensuring the company is meeting all of its pharmacovigilance responsibilities and that ultimately the safety of the public using the medicine is maximised. Choosing the right QPPV, whether as an employee for your organisation or a contracted partner is vital in helping your company reach its pharmacovigilance objectives.
PharmaConsult will provide the QPPV services as may be required please contact ;