farmacovigilant

Farmacovigilant is a term used to describe a professional or approach associated with pharmacovigilance—the science and activities focused on detecting, assessing, understanding, and preventing adverse drug reactions and other drug-related problems. Although pharmacovigilance is the standard English term, farmacovigilant (and farmacovigilante in some languages) may appear in multilingual contexts to refer to someone working in this field.

The field encompasses the ongoing monitoring of medicine safety across the product life cycle. A farmacovigilant collects and analyzes safety data from spontaneous reports, clinical studies, electronic health records, literature, and other sources; evaluates potential safety signals; and contributes to decisions about labeling, risk communication, and risk management plans. Core tasks include causality assessment of adverse events, signal detection, risk assessment, and the preparation of periodic safety update reports.

Regulatory frameworks shape practice. National agencies and international bodies—such as the US Food and Drug Administration, the European Medicines Agency, the World Health Organization, and ICH guidelines—require systematic pharmacovigilance activities. Key outputs include risk management plans, pharmacovigilance system master files, and periodic safety update reports, as well as measures to minimize risk and inform prescribers and the public.

Data sources and methods are central to the discipline. Spontaneous reporting databases (for example FAERS and VigiBase/EudraVigilance) are complemented by literature reviews and active surveillance. Methods include disproportionality analysis, causality assessment frameworks (e.g., WHO-UMC, Naranjo), and signal validation workflows.