**Pharmacovigilance (PV)** is the science and set of activities related to the **detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems**. It plays a critical role in ensuring drug safety throughout a medicine’s lifecycle — from clinical trials to post-marketing surveillance. ### Key Components of Pharmacovigilance - **Adverse Drug Reaction (ADR) Reporting**: Collecting and analyzing reports of harmful or unintended effects. - **Signal Detection**: Identifying new safety concerns or trends from case reports, databases, and literature. - **Risk Management**: Developing strategies to minimize risks associated with drug use. - **Post-Marketing Surveillance (Phase IV)**: Monitoring real-world drug safety after approval. - **Regulatory Compliance**: Meeting requirements of authorities like FDA, EMA, and MFDS (Korea). ### Why It Matters - Protects **patient safety** by quickly detecting harmful drug effects. - Helps healthcare professionals and companies **balance benefit vs. risk** of medicines. - Ensures **regulatory trust and compliance** for pharmaceutical companies. - Provides data for **updating drug labels, usage guidelines, or market withdrawal** if necessary. 👉 In short, PV is the backbone of **drug safety monitoring** and a continuous process that safeguards public health.