Pharmacovigilance, or PV, refers to a drug safety reporting system that systematically appraises, collects and reports suspected adverse events or safety "signals" as they relate to medicines post-launch, that is, in "real life use", after they have received marketing authorisation. It is aimed at enabling optimal use of Roche’s medicines in terms of safety on a sustainable basis.
Absolute safety is something we may be aiming at continually, but which can never be fully and completely attained. This particularly applies to pharmaceuticals and medicines. Doing everything in our power to safeguard patient safety, along the entire lifecycle of a medicine, is of paramount importance to us. To this end, we have a highly professional pharmacovigilance (PV) system in place which closely monitors all the suspected side effects, or adverse events, which have been reported in conjunction with our medicines, initiating all the necessary steps to address and remediate situations which may pose a health risk to the people taking our medicines.
Felix Arellano, Global Head of Drug Safety Risk Management at Roche, points out: "On top of these 2,000 safety experts, it is all of our 90,000-plus staff around the world who, strictly speaking, have a shared responsibility for safety. This is why our employees are kept in the loop by taking compulsory annual trainings in adverse event reporting. Also, our contractors and partners have to be fully aware of the company requirements for drug safety processes."
Kristof Vanfraechem, Head of International Pharmacovigilance in the Drug Safety Risk Management unit, echoes: "We obviously study our medicines in clinical trials, but much of the learning on the safety of our medicines happens post-launch during real life use. For instance, patients have other diseases or take other medicines that confuse adverse event diagnosis. Roche has a great network of Local Safety Responsibles across our affiliates. They are there to help employees link into the PV system, regardless of which country they work in."
Kristof emphasizes that while the safety people have to collect and process all of the information they can get hold of, it is the responsibility of the Roche professionals interacting with the external space to relay the information to the safety people. "We have an entire organization available at Roche that makes sure we analyze what is reported to us. The importance of getting this shared responsibility effectively executed across the organization is obvious."
Felix underlines this by saying: "There is not the one perfect Pharmacovigilance System to be adopted by everyone. But I am convinced that we have evolved and implemented the best possible system that works in the context of our culture and that fulfills all applicable requirements. For the safety function, it is imperative that people around the world work in consistent ways throughout the 95 plus countries in which we operate."