Safety Sentinel is a continuous, signal-grade pharmacovigilance layer that reads the public patient voice without ever creating a valid ICSR for the MAH. Awareness without obligation.
Regulators expect MAHs to regularly screen internet and digital media (EMA GVP VI Rev 2). The signal is out there. But every glimpse of an identifiable patient post risks meeting the four ICSR criteria and starting a 15-day clock. Most teams choose to look away. 94% of patient-reported safety experience never reaches anyone with the authority to act on it.
Reporter identifiability is removed before the MAH ever sees the data. Not workflow. Architecture.
GVP VI Rev 2 directs MAHs to screen digital media. Safety Sentinel operates exactly in that acknowledged space, without producing case-level awareness.
Pattern, frequency, clustering, emergence. Feeds GVP IX signal management. Never touches case intake.
Characterised as a signal-management support tool, not a case-intake source. Inspection-ready from day one.
It is a continuous signal layer alongside your existing PV architecture, always on between formal review cycles, the post-launch safety telemetry your asset's lifecycle has been missing. It is not a case-intake system, not a replacement for spontaneous reporting, and not active screening of MAH-managed properties.
QPPV and Head of PV: continuous safety signal from public digital media with no identifiable reporter, no valid ICSR, no reporting clock. Chief Medical and Safety Officer: post-launch safety telemetry that supplements EudraVigilance and FAERS without duplicating, expanding, or competing with them. Asset GM and Launch Lead: a real-time read on safety conversation around the asset, weeks before it would surface in regulatory data.