The Next Phase of Pharmacovigilance Needs a Broader View

Post-market safety monitoring has always played a critical role in protecting patients after drugs, biologics, and medical devices enter the market. But as the healthcare ecosystem moves faster, the signals that can point to emerging safety issues are becoming more complex, more fragmented, and more difficult to detect through traditional reporting alone.

In our new whitepaper, The Next Phase of Pharmacovigilance, we explore why federal health agencies, industry sponsors, and technology partners may need to take a broader, more real-time approach to safety monitoring. Traditional sources such as adverse event reports, claims data, electronic health records, clinical notes, and registries remain essential. But they can also be lagging and incomplete. To identify potential safety signals earlier, pharmacovigilance systems may need to incorporate additional indicators, including care-seeking patterns, changes in utilization, patient journey data, and other non-traditional signals that can support earlier hypothesis generation and faster signal triage.

AI and advanced analytics can help bring these signals together, identify weak patterns, and support continuous monitoring across large, heterogeneous datasets. But technology alone is not the answer. A modern pharmacovigilance model also depends on clinical validation, expert oversight, privacy protections, bias checks, transparent governance, and regulatory alignment. The goal is not broader surveillance for its own sake. The goal is to identify meaningful patterns earlier, validate them responsibly, and support better public health action.

Read the full paper to learn how health leaders can begin building a more proactive, signal-driven pharmacovigilance ecosystem, including practical steps for setting standards, investing in interoperable infrastructure, and launching focused pilots that can scale what works.