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Jonathan West has been a QPPV since 2007. To date he has been QPPV for 5 companies, and Deputy QPPV for several others.

As a QPPV, Jonathan has been inspected twice by the MHRA and once by Health Canada with no critical findings.

PhV Services have access to a network of independent QPPVs and PV Service Providers and can find the right QPPV or Deputy for your organisation.

QPPV Services

European legislation requires the Marketing Authorisation Holder (MAH) to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV). This named individual is responsible for the establishment and maintenance of the PV system and should have oversight of the safety profiles of the MAH’s medicinal product, and is the principle contact point for the Competent Authorities (24/7 on-call) for PV issues and PV inspections.

The QPPV should live and operate in the EEA, be experienced in all aspects of pharmacovigilance, and have back up procedures for business continuity (commonly by appointing a deputy QPPV). These regulated expectations often mean that such appointments are economically challenging for the smaller company. However, QPPVs can be subcontracted, together with other activities of the PV System.

PhV Services provide cost-effective QPPV services to the small and medium sized company. These services employ specific procedures that have been developed by PhV Services which promote efficiencies without compromising on compliance. The different levels of service are as follows:

1) Pre-appointment (due diligence) Audit of the existing PV System, or

2) Design and development of a new PV System

3) Registration of the QPPV with Eudravigilance

4) Develop and maintain the Summary of the PV System and the PSMF

5) Implement procedures to ensure the QPPV is regularly updated

6) Implement Quality Assurance procedures

7) Full oversight of the PV System

Please call +44 (0)1363 775981, email info@phvservices.com or click to discuss your requirements.