How to Build a Compliant Literature Search String for Pharmacovigilance: Why Most Teams Get It Wrong

 Ask ten pharmacovigilance (PV) teams to show you the exact Boolean search string used last week to monitor their flagship product, and most will struggle to produce it. They can produce the screening log, the case decisions, even the final ICSRs, but the literal query string, with all its operators, indexed terms, and database-specific syntax, often lives in someone’s PubMed account or a saved Embase session that no auditor can reproduce on demand.



This is the gap that turns an otherwise sound PV program into an inspection finding. The search string is not just a technical artefact. It is the foundation on which every downstream decision rests, and regulators have started treating it that way.

Why the Search String Is a Regulated Artifact, Not a Tool Setting

Under EMA’s Good Pharmacovigilance Practices Module VI, marketing authorisation holders are required to monitor scientific and medical literature systematically, at a minimum on a weekly cadence, using widely indexed databases such as Medline and Embase.The corresponding US obligation under 21 CFR 314.80 requires sponsors to file a 15-day Alert report for any serious, unexpected adverse drug experience identified in the scientific literature, with a copy of the article attached.

Both frameworks share a single underlying assumption: if the published evidence exists, the company is expected to have found it. The search string is the mechanism that makes that responsibility either defensible or indefensible.

GVP Module VI Appendix 2.3.4 is explicit on the point that matters most to inspectors. Regulators do not accept any reduction in recall as a valid trade-off when monitoring published literature for safety information. Precision can be tuned to manage workload, but missing a relevant ICSR sits outside the acceptable boundary.

That single principle reshapes how search strings should be built. The goal is not the cleanest result set. The goal is a defensible recall floor of effectively 100% against the universe of articles that could plausibly contain a reportable adverse reaction. Most teams build for the opposite outcome, often without realising it.




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