Pharmacovigilance
An adverse reaction is a response to a medicinal product which is noxious and unintended. Commonly an adverse reaction is referred to as a “side effect”.
Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine’s authorisation, it has been tested in a relatively small number of selected patients for a limited length of time.
After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances.
Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce risks and increase benefits from medicines. Pharmacovigilance is essential part of the product lifecycle: Research and development, Marketing authorisation and Post-authorisation.
It is the MAHs responsibility to comply with EU pharmacovigilance legislation. MAH may subcontract certain activities of the pharmacovigilance system to third parties.
Sirius can be your pharmacovigilance partner, taking care of all activities related to Pharmacovigilance that can be delegated by MAH to a third party: Offer the service of QPPV and medically qualified person, Eudravigilance, Risk Management, Pharmacovigilance system, Medical literature monitoring, Signal management, PSUR etc.