Kinetic Gain · Pharmacovigilance Signal Router
synthetic safety signals · no patient-identifiable or sponsor-confidential data
Biotech / diagnostics safety routing proof C# · patient-safety and regulatory workflow depth Hosted preview planned · Embedded by engagement

Safety signals, routing gaps, and review posture that stay operator-readable.

This control plane turns synthetic pharmacovigilance exports into one review surface: case completeness, seriousness assessment, MedDRA coding, follow-up closure, aggregate reporting evidence, and named signal actions before committee decisions harden around weak packets.

OverviewSignal LaneCase RoutingSafety PostureVerificationDocs

Safety Posture

packet readiness · blocker · timing
54%
Safety Operations

Cardiac intake packet

Do not let a partially described serious case move downstream without a defensible intake packet.

  • Case completeness is still missing a confirmed onset date and seriousness rationale.
  • 6 hours to the next safety review checkpoint
  • Status: red
PVSR-14
59%
Regulatory Affairs

Hepatic signal packet

Do not let the signal committee close review while the reporting evidence is still incomplete.

  • The aggregate reporting packet still lacks the locked case-set export and literature addendum.
  • 12 hours to the next safety review checkpoint
  • Status: red
PVSR-21
76%
Patient Safety

Pediatric follow-up packet

The lane can recover if reporter follow-up lands in the next review window.

  • Two cases still lack second-round follow-up needed to confirm dechallenge outcome.
  • 18 hours to the next safety review checkpoint
  • Status: yellow
PVSR-27
71%
Medical Review

Medical review packet

Committee posture can recover if medical review closes before the next signal meeting.

  • Hospitalization criteria and one MedDRA coding set still need correction before signoff.
  • 9 hours to the next safety review checkpoint
  • Status: yellow
PVSR-30
pharmacovigilance-signal-router · synthetic sample data only
GitHub · LinkedIn · Kinetic Gain
routes: / · /signal-lane · /case-routing · /safety-posture · /verification · /docs