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.
| Lane | Owner | Status | Focus | Next action |
|---|---|---|---|---|
| Case intake and triage lane The intake queue is currently the biggest safety-handling pressure point. |
Safety Operations | red | Serious case completeness, reporter traceability, and ready-for-review intake packets | Close the missing onset date and seriousness rationale before another intake packet escalates with a blind spot. |
| Medical review and coding lane Medical review posture is not committee-safe yet. |
Medical Review | red | Seriousness assessment, MedDRA coding, and medically significant narrative review | Correct the hospitalization classification and close the open coding drift before the next committee pass. |
| Follow-up and reporter closure lane Follow-up posture is recoverable if the next outreach closes on time. |
Patient Safety | yellow | Reporter questions, affiliate handoffs, and evidence completeness for open pediatric cases | Close the overdue follow-up questions before the next review cycle hardens the open unknowns. |
| Aggregate reporting and signal committee lane The signal packet is not yet escalation-safe. |
Regulatory Affairs | red | Periodic reporting evidence, literature review continuity, and named action ownership | Close the missing case-set export and literature addendum before another hepatic signal review cycle opens. |