An open framework quantifying the risk-adjusted value of agentic AI for pharmacovigilance and safety-signal detection. Built for QPPVs, Heads of PV, and CMOs evaluating Safety Sentinel against the cost of current spontaneous-reporting architecture.
Signal-detection lead time, label-change avoidance, post-market commitments, inspection readiness, and the cost-of-ignorance baseline that current PV operating models bake in.