Pharmacovigilance teams are routinely asked to justify their staffing. Too often the answer is some version of "this is what we have always done." At inspection, that is not an answer.
Risk is not uniform across a portfolio
Different products carry very different safety-signal loads. Allocating PV resource evenly across a portfolio over-serves low-risk products and under-serves high-risk ones.
FAERS as the evidence base
The FDA Adverse Event Reporting System provides a real-world signal of where adverse-event activity concentrates. Used properly, it supports drug-risk tiering that resource allocation can be built on.
Defensible by design
Our PV Resource Allocation Tool turns FAERS-driven risk tiering into staffing plans that are inspection-ready and audit-traceable, so the answer to "why this allocation?" is always evidence.
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