Pharmacovigilance System Outsourcing

Provision of EEA Qualified Person for Pharmacovigilance (EEA QPPV)

PrimeVigilance offers experienced EU Qualified Person for Pharmacovigilance (QPPV) and Deputy QPPVs with extensive knowledge and experience of the industry.

Your medicinal products cannot be marketed within the EU without a Qualified Person for Pharmacovigilance (QPPV) that is personally responsible in law for the fulfillment of key functions:

    1. Establishing and maintaining your pharmacovigilance (PV) system, including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities
    2. Overseeing the safety profiles of your company’s marketed products and any emerging safety concerns
    3. Acting as a single point of contact for the EMA and EU Competent Authorities on a 24-hour basis, and the contact point for inspections
    4. Ensuring and verifying that the pharmacovigilance system master file (PSMF) is constantly an accurate and up-to-date reflection of that safety system

Your QPPV must reside with the EEA and be permanently and continuously at the disposal of the marketing authorisation holder (MAH) and must be experienced in all aspects of pharmacovigilance.

Why Outsource Your Qualified Person for Pharmacovigilance?

Recruiting and appointing your QPPV can consume a great deal of your time and resources. Our support allows for greater economy without sacrificing quality.

PrimeVigilance QPPVs have extensive knowledge and experience of the industry and reside in more than one EU member state.

Our experienced QPPVs can work within your PV system which has been outsourced to PrimeVigilance.

PrimeVigilance 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.

PrimeVigilance also offer an extensive network of National Persons Responsible for Pharmacovigilance (NPRP – also known as local QPPVs or Local Contact Persons) who are the primary contact person for their local competent authority and work closely with the EEA QPPV e.g. the German Stufenplanbeauftragter or Graduated Plan Officer as defined in section 63a of the German Drug Law.

Just one of the pharmacovigilance services from PrimeVigilance

For more information contact PrimeVigilance today

References:
1European Medicines Agency. 22 June 2012 EMA/541760/2011. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems.

2Brown EG. The Qualified Person for Pharmacovigilance for Europe: a compliance and quality perspective. Leading article. Int J Pharm Med 2005; 19 (1): 7-14