Insight Review on Data Quality Management in Pharmacovigilance

Pharmacovigilance is the scientific system developed to ensure the overall safety of a medicinal product by precise collection, compilation, and assessment of adverse drug-related events. The review focuses on the accurate evaluation of all the risk factors relevant to medicinal product use depending upon how precisely the adverse event data has been handled and processed to maintain by implementing quality standards at several stages, such as data entry, database selection, processing, and storage; this high-quality data can be obtained and maintained. In addition, the timeline in which data is received and reported to regulatory authorities is of vital importance. This review highlights key aspects of data quality management in pharmacovigilance focusing on data processing, management and its designing, regulatory guidelines, timelines for reporting of safety data, and the periodic safety update report (PSUR) process. Furthermore, the importance of reference safety information (RSI) and pharmacovigilance during healthcare emergencies is also highlighted. The evolution of pharmacovigilance systems, driven by automation and the WHO Drug Dictionary (WHO-DD) is examined, demonstrating how these developments enhance global safety monitoring, data accuracy, and reporting effectiveness. Therefore, for pharmacovigilance to ensure drug safety, high-quality data management is essential. Pharmacovigilance systems can be made more effective and efficient by utilizing digital tools and real-world data via automation and future technological improvements that can simplify data gathering and analysis.