Harmonizing Pharmacovigilance and Pharmacoepidemiology: Lessons from Europe for Cohesive Medicines Safety Science

The overarching aim of medicine safety science is to generate evidence that supports the safe and effective use of medicines through better therapeutic decision making and the protection of avoidable harm. Pharmacovigilance (PV) and pharmacoepidemiology (PE) have historically evolved along different scientific, organisational and regulatory pathways and therefore are often described as separate, albeit closely related disciplines: one focused on case processing, ongoing safety surveillance, signal detection, and risk management; the other on population-level patterns of medicine use and outcomes, using observational methods to quantify associations, and support causal inference.

While this distinction has been useful in defining roles and responsibilities, it is becoming increasingly misaligned with the way medicine safety evidence is now generated, evaluated, and applied across the lifecycle of medicines. Increasingly, complementary data sources and methodologies contribute to a shared evidence ecosystem in which PV and PE provide different, but interdependent, perspectives on medicines safety.

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Layton, D., Rishiraj, P. Harmonising Pharmacovigilance and Pharmacoepidemiology: Lessons from Europe for Cohesive Medicines Safety Science. Drug Saf (2026). https://doi.org/10.1007/s40264-026-01713-2