Pharmacovigilance

Definitions #

The science of monitoring and evaluating the safety of medicines after they are approved for use.

Technical Per EU Directive, the systematic collection and analysis of adverse drug reactions and other drug-related safety data to prevent harm to patients.

Etymology #

From 'pharmaco-' (drug) + 'vigilance' (watchfulness), coined to mean 'watching over drug safety.'

Collocations #

adverse drug reaction (ADR) 有害药物反应，亦称不良反应
signal detection 信号检测，指从数据中识别潜在安全风险

Real Business Examples #

The pharmacovigilance team submitted a periodic safety update report to the regulator.
Pharmacovigilance activities include collecting reports of adverse events from clinical trials and post-marketing use.
The company's pharmacovigilance system must comply with Good Pharmacovigilance Practices (GVP).

Register & Variants #

Register: formal
BrE/AmE: 全球通用

Synonyms & Antonyms #

Synonyms: drug safety surveillance

Common Errors #

Confusing pharmacovigilance with clinical-trial monitoring. Pharmacovigilance covers the whole lifecycle of a drug, not just trials; it emphasizes post-marketing surveillance.

Confusable Terms #

Post-marketing surveillance vs Pharmacovigilance: A component of pharmacovigilance focused on drug safety after market entry.

Frequently Asked Questions

Why is pharmacovigilance important??

It helps detect rare or long-term side effects not identified in clinical trials, ensuring drug safety.

Published: 2026-09-22 Category: Regulatory