What is Pharmacovigilance?

Pharmacovigilance (also called drug safety) is responsible for monitoring data for adverse events associated with drug therapy. The group collects, organizes, and analyzes a constant in-flow of data to look for potential adverse drug reactions and works with regulatory colleagues to report them to regulatory agencies as required.

Adverse event reports can come in through many different mechanisms including direct patient reports through avenues like medical information, reports from physicians on visits by field personnel, and large datasets that the company may license. Employees and contractors of pharmaceutical companies are generally also required to report any adverse events they hear about anywhere whether in professional or personal settings for drugs produced by the company they work for.

Professionals in pharmacovigilance may work on post-marketing monitoring or monitoring of clinical trial safety data prior to approval (or potentially after for ongoing trials).