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.
| Risk | Owner | Subject | Observed state |
|---|---|---|---|
| high Case Intake |
Safety Operations | Initial case intake completeness | Three incoming cases still lack a confirmed event onset date and one seriousness rationale is missing from the intake packet. |
| high Seriousness Assessment |
Medical Review | Medical seriousness assessment | One case is still marked non-serious even though the narrative describes an overnight hospitalization. |
| medium MedDRA Coding |
Case Processing | MedDRA coding consistency | Two pediatric rash cases still carry local free-text terms instead of the approved MedDRA coding set. |
| high Aggregate Reporting |
Regulatory Affairs | Periodic safety report evidence | The hepatic signal packet still lacks the locked case-set export for the next periodic reporting cycle. |
| medium Follow-Up |
Patient Safety | Reporter follow-up closure | Two pediatric cases still lack the second-round follow-up needed to confirm dechallenge outcome. |
| high Signal Review |
Signal Committee | Signal committee packet | The current hepatic packet still lacks the literature-review addendum and the named action owner for escalation. |