Pharmacovigilance organizations are navigating an increasingly complex landscape in which adverse event data flows from a growing number of sources, including email, web portals, patient support programs, electronic health records, call centers and medical literature. At the same time, reporting timelines remain stringent, regulatory scrutiny continues to intensify and millions of case reports accumulate across global safety ecosystems. Despite advances in technology, 65% to 70% of safety operations effort is still consumed by intake, data entry, validation, coding and other manual activities, creating inefficiencies that can slow the path from intake to actionable safety insights.

The challenge is no longer just managing volume but ensuring every decision is supported by the right evidence, context and traceability. As demand for experienced pharmacovigilance professionals outpaces available talent, the gap between workload and expertise continues to widen. To bridge that gap, safety leaders need connected, intelligent approaches that enable evidence-driven decision-making across the lifecycle.

Built around the principle of evidence-based decision-making, HCLTech Intelligent Safety Platform (ISP) helps organizations connect data, workflows and insights across the pharmacovigilance lifecycle, creating a seamless journey from intake to signal.