Insights
PV Intelligence &
Industry Insights
Deep dives into AI pharmacovigilance, regulatory science, and drug safety technology. Double-click any article to read the full writeup.
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AI in Pharmacovigilance
Why Oracle Argus Cannot Compete with AI-Native Pharmacovigilance
Legacy platforms bolt AI onto existing workflows. SafetySignal builds from the model up — and the difference shows in every causality assessment.
2026-03-15 · 8 min readDouble-click to read
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Regulatory Science
Automating ICH E2B(R3) Submissions: The End of Manual ICSR Authoring
E2B(R3) XML generation is largely manual today. SafetySignal automates the full ICSR lifecycle from structured case data to submission-ready XML.
2026-03-10 · 6 min readDouble-click to read
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Signal Science
The BRAT Framework for AI: Building the First AI-Native Benefit-Risk Engine
Benefit-risk assessment is one of the most complex judgment calls in regulatory PV. Here's how we encode the BRAT framework into an automated scoring system.
2026-02-28 · 7 min readDouble-click to read
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Pharmacovigilance Operations
Signal Prioritization in the Age of AI: Moving Beyond PRR and ROR
Statistical disproportionality methods like PRR and ROR are necessary but not sufficient. Composite priority scoring changes how PV scientists work.
2026-02-20 · 5 min readDouble-click to read
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Regulatory Intelligence
CIOMS XIV Compliance Automation: What 94% Really Looks Like
CIOMS XIV sets a new benchmark for AI governance in pharmacovigilance. SafetySignal is the first platform built to comply from day one.
2026-01-30 · 6 min readDouble-click to read
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Technology
Building SafetySignal-PV-7B: Fine-Tuning a Language Model for Pharmacovigilance
How we trained a 7.6B parameter model for adverse event causality assessment — and why general-purpose LLMs aren't enough.
2026-01-15 · 9 min readDouble-click to read