Pharmacovigilance

Pharmacovigilance Explained

What is Pharmacovigilance?

Pharmacovigilance (PV) is the a science relating to the detection, assessment, understanding and prevention of adverse drug reaction or events or side effects of various pharmaceuticals drugs and medicines.

By definition, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicinal products.

The word is derived from the Greek pharmakon – drug, and the Latin vigilare – to be awake or alert, to keep watch.

In general, there are two types of Pharmacovigilance is practiced in the regulated market, one which deals with drugs under clinical trials stage, another deals with post marketing phase of the drug.

Pharmacovigilance requires collection of the data from various sources, three main sources of data being regulatory agency, literature searches and complaints registered directly to the marketing companies.

Pharmacovigilance software is needed to make sure that each adverse event report data is captured accurately, with complete history of the patient and the medication and then analyze them collectively to derive specific data on possible adverse events of any medicinal product.

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