Pharmacovigilance

Pharmacovigilance(PV)

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions.

Usage Examples

The pharmacovigilance system detected a new safety signal.
All adverse events were reported to the PV department.
The company maintains a global pharmacovigilance database.

What is PV?

Pharmacovigilance (PV) encompasses all activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It continues throughout the entire lifecycle of a medicinal product, from development through post-marketing.

PV activities include adverse event collection and reporting, signal detection and evaluation, risk management, periodic safety reporting (PSURs/PBRERs), and communication of safety information. Marketing authorization holders are legally required to maintain PV systems and report safety data to regulatory authorities.

The goal of pharmacovigilance is to improve patient safety by continuously monitoring the benefit-risk profile of medicines and taking action when necessary.

Regulatory Context

This term appears most often in pharmacovigilance workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 314 80, ICH E2A, ICH E2B.

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When This Matters

The pharmacovigilance system detected a new safety signal.
All adverse events were reported to the PV department.
The company maintains a global pharmacovigilance database.

Common Mistakes

Treating safety signal reviews as periodic instead of continuous.
Not linking new enforcement letters to internal CAPA and labeling workflows.
Using static templates for dynamic benefit-risk communication updates.

Related Regulations

21 CFR 314 80ICH E2AICH E2BEU GVP

Frequently Asked Questions

The terms are often used interchangeably. Pharmacovigilance is the broader science and system, while drug safety may refer specifically to safety data management and reporting functions.

Serious and unexpected adverse reactions must be reported to regulatory authorities within 15 calendar days (7 days for fatal/life-threatening). These expedited reports are called ICSRs (Individual Case Safety Reports).

A Qualified Person for Pharmacovigilance (QPPV) is the EU requirement for a designated individual responsible for the establishment and maintenance of a company's pharmacovigilance system.