Understanding the Global Pharmacovigilance System

Medicines undergo rigorous clinical testing before approval, but clinical trials cannot capture every potential safety risk. Once a medicine is used by thousands or millions of patients, new safety information may emerge.

Pharmacovigilance is the global system designed to monitor the safety of medicines after they reach the market. Its purpose is to detect potential safety signals, evaluate adverse reactions and ensure that medicines continue to provide more benefit than risk to patients.

Across Europe, pharmacovigilance activities are governed by the European Union pharmacovigilance legislation and implemented through Good Pharmacovigilance Practices (GVP). These guidelines define how pharmaceutical companies and regulatory authorities must collect, analyse and report safety data.

Pharmacovigilance professionals play a central role within this system. Their responsibilities include reviewing adverse event reports, identifying safety signals, analysing benefit-risk data and supporting regulatory reporting obligations.

As medicines continue to evolve and healthcare systems generate increasing volumes of real-world data, pharmacovigilance professionals are becoming increasingly critical to ensuring patient safety worldwide.