What is pharmacovigilance?
Pharmacovigilance is the ongoing process of monitoring the safety of pharmaceutical products once they are in clinical use. It involves the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other medication-related issues. Activities include the collection and analysis of safety data from spontaneous reports, post-marketing surveillance studies, electronic health records, and other real-world sources. Pharmacovigilance also encompasses signal detection, risk assessment, and regulatory reporting.
Why is pharmacovigilance important in the pharmaceutical industry?
Pharmacovigilance is essential for ensuring patient safety, maintaining regulatory compliance, and preserving public trust in medicines. It helps identify rare or long-term side effects that may not be evident during clinical trials and supports timely updates to product labeling, prescribing guidance, and risk management plans. For pharmaceutical companies, robust pharmacovigilance systems are a regulatory requirement and a core component of responsible product stewardship across the entire lifecycle.