Abstract:
Background. Pharmacovigilance, the cornerstone of public health, is being transformed by
technological advances, in which artificial intelligence (AI) plays an important role in
minimizing conventional approaches, characterized mainly by human errors and scalability
issues in monitoring adverse reactions.
Objective(s). Researching the prospects for using artificial intelligence in the field of
pharmacovigilance and the techniques used in monitoring and evaluating adverse drug
reactions to guarantee patient safety.
Materials and methods. Systematic, analytical-descriptive study of EMA, WHO, FAERS
directives and reports, laws, orders of the Ministry of Health, AMED, journals listed in
electronic databases (Pubmed, EMBASE, SCOPUS). The search employed a range of
keywords pertinent to the research topic, including but not limited to "artificial intelligence"
and "adverse reactions."
Results. Globally, the VigiBase platform, developed by WHO, integrates advanced tools such
as VigiRank, VigiMatch and VigiGrade, which use specific algorithms to prioritize and
evaluate reports on adverse drug reactions, transmitted by over 130 countries. In parallel,
the Sentinel system, developed by the U.S. FDA, leverages real-world data and applies
modern machine learning and natural language processing techniques to monitor drug
safety. Within the pharmaceutical industry, IBM Watson for Drug Safety is a reference AI
solution, contributing to compliance with the requirements for compliance with Good
Pharmacovigilance Practices imposed by EMA.
Conclusion(s). Realizing the full potential of AI in pharmacovigilance demands close
collaboration among regulatory bodies, healthcare professionals, and AI developers to
ensure process validation, ethical compliance, and continuous human oversight in
monitoring adverse drug reactions.
