PVpharm
Solving the Riddle of Pharmacovigilance Compliance

Pharmacovigilance has become one of the primary health functions today. Its significance in the current times has escalated with the drug approval process being expedited, necessitating faster roll out into the market. The European region is the second-largest market for pharmacovigilance in the world after North America, is home to one of the most sophisticated pharmacovigilance systems. With that comes the demand for consultants who can understand the intricate system and guide the pharmaceutical industry through the labyrinth of regulations.

PVpharm is one such team of consultants based in Spain and operating worldwide that fits the bill. Having guided, audited, and trained a multitude of players in the European pharmaceutical space, the company has fulfilled varying demands of businesses, ranging from instilling the pharmacovigilance culture from scratch to rendering strategic advice. With its professional and tailored approach, the company collaborates with marketing authorization holders that need to have support for pharmacovigilance for their drugs and also provide support to service providers that require more sophisticated pharmacovigilance advice. “A deficiency in the system can cause a product to be withdrawn from the market, leading to serious economic repercussions for the company. We make sure that the requisite steps are taken by our clients so that the quality of drug is as per the mandatory standards,” says Jose Ortiz, CEO of the company and a pharmacovigilance consultant.

When approached by a client, PVpharm assesses the pharmacovigilance systems of the company. Being experts in auditing services, it undertakes an independent audit of the client’s systems.

It identifies the parts of course that need improvement and provides suggestive measures for enhancement of risk management, control, and governance processes. “Improving the quality is a continuous process and this is what we enable and ensure,” adds Ortiz.

Understanding the legislation and the quality systems focus of pharmacovigilance is essential for protecting patient`s safety and for succeeding as a company

Given the fact that the European Union is a diverse region with different languages, even though the European legislation is common for all countries, there are some additional requirements for each country. Hence, pharma companies need a qualified person for pharmacovigilance (QPPV) who resides in the EU and is continuously available. PVpharm meets their demand by offering services for both EU QPPV and Local PV contact persons in all EU countries who transfer their knowledge to the pharmacovigilance system so that the enhanced system can live up to the expectations of regulatory bodies. The company also provides a Deputy QPPV service wherein a professional works closely with the client’s QPPV and can fill in his shoes whenever needed.

An example that proves the capability of PVpharm is the fact that a global pharmacovigilance service provider which is a powerful company with no dearth of resources has given the strategic position of a QPPV to PVpharm. Another example is of a small company that has limited knowledge of pharmacovigilance and has roped in PVpharm to take responsibility for all of its pharmacovigilance services. Moreover, many leading pharma companies have been receiving training from PVpharm about specific parts of pharmacovigilance and many CROs choose PVpharm as their strategic partner in Spain.

Growing as a company, PVpharm realizes that there is an increasing awareness about pharmacovigilance amongst companies, and it plans to collaborate with them and work on some strategic partnerships. “We are reinforcing the quality aspects of our company through a quality department. We include more and more people in the quality department as it is one of the most important departments in pharmacovigilance,” signs off Ortiz.