This is the second in a three-part blog series on National Pharmacovigilance systems and the role of technology in bridging the gaps in pharmacovigilance of regulatory authorities around the world.

Life sciences companies confront increasingly stringent requirements on safety signal detection and risk management. Regulatory authorities are taking steps to further safeguard patients by requiring companies to take more comprehensive steps to assess and monitor the benefit-risk balance of their products.

For many companies, signal detection in drug safety pharmacovigilance ranks closely behind regulatory submissions and case management as a key activity because it helps to proactively monitor a product’s risks that come to light from tracking the data submitted to internal and external drug safety databases and platforms.