Pharmacovigilance and Adverse Event Reporting: A Comprehensive Review of Global Practices and Emerging Trends

It encompasses all of the scientific endeavors pertaining to the detection, assessment, comprehension, and avoidance of any negative effects or other issues associated with drugs. The definition, elements, goals, and historical development of pharmacovigilance are summarized in this paper along with important terms like adverse drug reactions (ADR), adverse events (AE), and signal detection. This document completes the whole pharmacovigilance process as well as providing sources of safety data, various adverse event reporting methods, and the applicable global regulatory framework involving WHO, FDA, EMA, ICH, and CDSCO. Other issues include advanced tools and technologies such as electronic reporting, AI-based analytics, and software platforms such as VigiBase and MedDRA. Underreporting, data quality issues, and global harmonization, along with some real-life case studies such as thalidomide and COVID-19 vaccines, have been discussed with regard to challenges. The paper concluded with future perspectives including reality evidence, patient-centered reporting, and incorporation into public health strategies, thereby augmenting the critical role that pharmacovigilance plays in the prevention of misuse of drugs and diminishing public trust.