Qualified Person for Pharmacovigilance (QP PV) Services

It is a mandatory requirement for all the medicinal products authorized in the European Union to appoint a Qualified Person for Pharmacovigilance (QPPV). QPPV is responsible for ensuring that the Marketing Authorization Holders comply with the EU, UK, and Australian regulatory requirements. We are experienced in providing an experienced QPPV to oversee and support our client’s portfolio. Most organizations outsource the QPPV as it is both efficient and cost-effective as they can gain access to the expertise of QPPV within the EU, UK and Australia.

Services offered by our experienced QPPV

QPPV will establish and maintain the PV system in the EU. They will also be promoting, improving, and maintaining legal compliance requirements within the European Union, UK, and Australian region. QPPV will also maintain the awareness of risk and have minimization measures for the medicinal product and they will also have authority over the Risk Management Plan content. They will review and approve the protocols of any Post Authorization Safety Studies conducted in the European Union. Ensure all the documents related to pharmacovigilance are in accordance with legal requirements. They will also check the correctness of the data submitted to the European Medicines Agency and competent authorities. QPPV will also oversee the emerging safety concerns and safety profiles relating to the medical products covered by the PSMF. A QPPV is highly important for a pharma company as it will act as a single point of contact for the EMA, and CAs. They will provide prompt responses to the CA’s requests and also provide input regarding the preparation of regulatory action in the European Union.

Local Pharmacovigilance representatives in the EU

In certain member states of the EU, it is mandatory to nominate a pharmacovigilance person at the national level. The role of local QPPVs is to provide the National Competent Authority with a local contact person. The prerequisites for becoming the local QPPV are that they must be residents of the country and be fluent in the national language, they will also be required to oversee the local PV system for collecting, monitoring, and reporting the safety information to the concerned authorities. Vizen life sciences have a complete understanding of all the EU countries and their requirements. We will provide you with a local representative to meet any specific requirements.

Vizen Life Sciences can source you experienced QPPVs from countries such as France, Belgium, Italy, Germany, Spain, Poland, Netherlands, etc.