Drug safety is all about the right patient receiving the right drug at the right time for an improved outcome for each patient. To achieve this, a Qualified Person Responsible for Pharmacovigilance (QPPV) is held responsible for the pharmacovigilance management of the quality of a pharmaceutical company. This could be a person who encourages action, rather than reaction, from setting up a pharmacovigilance system to being a point of contact for concern from a regulatory authority. Sometimes, a QPPV may be needed on a managerial level in one area and sometimes they may have a taskmaster responsibility. Hence, apart from scientific skills and medical knowledge, the QPPV must also have various abilities to accomplish the required aims regarding drug safety. The QPPV has the authority to assign multiple tasks to many people, which can be efficiently conducted. However, the QPPV cannot allocate pharmacovigilance system management.
So, there is a need to train QPPV on the assignment of work. Thus, with effective allocation of tasks, people can use their knowledge and skills effectively without hindering the system’s quality. So, for some activities, QPPV has to say “Do exactly what I Say” which means these activities are related to directives and regulations provided by the regulatory authority without any assigned independence at all from the QPPV who holds full supervision. However, for some actions, QPPV can say “Give me your suggestion and the other alternatives. I’ll let you know whether you can proceed.” This means these activities are guidelines provided by the regulatory authority and one can examine and propose but with a check on the rationale before reaching a conclusion while maintaining compliance with regulations. To distinguish activities that are related to directives or regulations, those that require close watch, or those that are related a guideline of the regulatory authority alone is not enough; there is a strong need to train QPPV before going live in the pharmacovigilance system.
– Ritu Mishra
“Ritu Mishra is a Group lead in pharmacovigilance department in DDReg”