«Pharmacovigilance system» is a system organized by the holders of registration certificates for medicinal products and authorized bodies of the member states of the Eurasian Economic Union to fulfill the tasks and responsibilities of pharmacovigilance, designed to control the safety of medicinal products, timely detection of all changes in the assessment of the ratio — the risk of «drugs, development and implementation of measures to ensure the use of drugs when the benefit exceeds the risk [1].
The marketing authorization holder may delegate all or part of his / her pharmacovigilance tasks, including the functions of a Pharmacovigilance Authorized Person (PAD), to another organization or person (if the same requirements can be applied to such person as to the organization). [1].
When outsourcing pharmacovigilance tasks, responsibilities that are usually performed internally are assigned to a specialized service provider (outsourcing company). From an economic point of view, this approach is justified, since this method allows you to reduce the cost of pharmacovigilance activities.
At the same time, the holder of the marketing authorization is responsible for the fulfillment of tasks and responsibilities for pharmacovigilance, ensuring the quality and integrity of the pharmacovigilance system. [1].
It is very important to choose the right outsourcing company that provides pharmacovigilance services, and this makes choosing an outsourcing partner even more important.