SAFETY SIGNAL IN PHARMACOVIGILANCE

Abstract

Every drug has a potential to produce adverse effects. Pharmacovigilance focuses on adverse
drug reaction (ADR) signals of medicinal product. It ensures that the patients get safe drugs.
More than a single report of ADR is required to generate a valid signal. Information in the
reports should be of good quality. Identifying signal with the help of event data from any
source called as signal detection. It is the process of monitoring safety data. Detection of new
risk can have great impact on the benefit-risk profile of the drug. Detection of signal in post
marketing is a crucial task. Signal detection depends on the variety of data sources. These
sources are analyzed for signal detection purposes. Different ADRs requires different
strategies for detection.