Precision pharmacovigilance integrates genomics and real world evidence to overcome drug safety barriers

Pharmacogenomics provides proactive, mechanistic insights into adverse drugreactions, while pharmacovigilance ensures reactive, real-world monitoring. Thisarticle describes their integration into precision pharmacovigilance, a synergisticparadigm that is transforming drug safety. By linking the why of geneticpredisposition to the what of population-level outcomes, this approach enablesa fundamental shift from problem detection to proactive, personalized harmprevention. Here we explore the digital ecosystem—electronic health records,artificial intelligence and real-world data—that underpins this integration. Theclinical potential is illustrated by compelling case studies: preventive HLA-B*15:02screening has virtually eliminated carbamazepine-induced SJS/TEN in certainpopulations, and analysis of national databases shows that a small panel of genescould prevent a significant proportion of adverse events. Despite these promisingresults, widespread application is hampered by systemic hurdles. These includethe lack of data standardization, regulatory fragmentation and a critical knowledgegap among physicians that undermines trust and hinders adoption. Unlocking thispotential will require a multi-pronged effort across technology, policy and practice.Technologically, the development of trustworthy and explainable artificial intelligenceis critical to building trust in the clinic. Policy makers need to establish data standardsfor interoperability, create clear reimbursement for pharmacogenomic testing, andharmonize regulatory guidelines. Critically, healthcare systems must foster a cultureof continuous learning that enables clinicians to interpret and apply genomic dataeffectively. Removing these systemic barriers can finally close the gap betweeninnovation and implementation and usher in an era of safer, truly personalizedmedicine.