Pharmacovigilance encompasses the comprehensive system of activities designed to monitor the safety of medicinal products throughout their entire lifecycle, from early clinical development through post-marketing surveillance. This discipline integrates scientific methodology, regulatory compliance, and public health protection to ensure that the benefits of therapeutic interventions continue to outweigh their risks across diverse patient populations and clinical settings. The ultimate goal of pharmacovigilance is to promote safe, effective use of medicines while minimizing preventable harm.

During clinical development, pharmacovigilance activities focus on identifying and characterizing the safety profile of investigational products through systematic collection, processing, and analysis of adverse event data. This includes establishing processes for adverse event reporting by investigators, coding and entering safety data into databases, detecting potential safety signals, conducting causality assessments, and preparing regulatory safety reports. The sponsor must maintain a pharmacovigilance system capable of fulfilling these obligations across all trials of the investigational product simultaneously.

Post-marketing pharmacovigilance continues the safety monitoring that began during clinical trials but extends to the much larger and more diverse population exposed to marketed products. Activities include operating adverse event reporting systems for healthcare professionals and consumers, conducting post-authorization safety studies, analyzing real-world data from electronic health records and claims databases, and implementing risk minimization measures when necessary. Regulatory requirements mandate that marketing authorization holders maintain pharmacovigilance systems, designate qualified persons responsible for pharmacovigilance, and submit periodic safety update reports summarizing the benefit-risk balance of their products.