Adverse event queue,
signal detection, multi-regulator.
18 synthetic AE cases across 4 marketed products · 6 active signal-detection patterns · 8 regulator routes mapped · ed25519-signed PV audit chain. The operator surface a pharma PV team uses between case-intake and submission.
Adverse event queue — Helios Therapeutics
18 synthetic AE cases (open + recent) across 4 marketed products (3 drugs + 1 implantable device). 2 expedited 7-day cases (death-related + unexpected anaphylaxis), 4 due within 48h, plus 5 Drug X QT-prolongation cluster cases that triggered signal detection.
| Case ID | Product | Term | Severity | Reporting route | Deadline | Causality | Status |
|---|---|---|---|---|---|---|---|
| AE-2026-0892 | Drug X (Helios-DRX) | QT prolongation, severe | Serious | MedWatch 15-day | Day 12 of 15 | Causality pending | Due ≤48h |
| AE-2026-0891 | Drug Y (Helios-PRO) | Hepatic enzyme elevation | Serious | MedWatch 15-day | Day 4 of 15 | Probable causal (Naranjo 6) | In review |
| AE-2026-0890 | Drug X (Helios-DRX) | QT prolongation, moderate | Serious | MedWatch 15-day | Day 7 of 15 | Causality pending | In review |
| AE-2026-0889 | Device D-7 (Helios-IMP) | Device migration post-implant | Serious | FDA MDR 30-day | Day 23 of 30 | Probable causal | Due ≤48h |
| AE-2026-0888 | Drug Z (Helios-NEU) | Headache, mild | Non-serious | Periodic (PSUR) | Q3 cycle | Non-causal (case 1004) | Complete |
| AE-2026-0887 | Drug X (Helios-DRX) | QT prolongation, severe | Serious | MedWatch 15-day · EU MDR | Day 2 of 15 | Causality pending | In review |
| AE-2026-0886 | Drug Y (Helios-PRO) | Anaphylaxis, severe | Serious + Unexpected | MedWatch 7-day expedited | Day 1 of 7 | Probable causal | 7-day expedited |
| AE-2026-0885 | Drug Z (Helios-NEU) | Insomnia, mild | Non-serious | Periodic (PSUR) | Q3 cycle | Possible causal | Complete |
| AE-2026-0884 | Drug X (Helios-DRX) | Syncope, moderate | Serious | MedWatch 15-day | Day 9 of 15 | Possible causal | In review |
| AE-2026-0883 | Device D-7 (Helios-IMP) | Device failure, no patient harm | Non-serious | FDA MDR 90-day (malfunction) | Day 47 of 90 | N/A device failure | In review |
| AE-2026-0882 | Drug Y (Helios-PRO) | Hepatic enzyme elevation | Serious | MedWatch 15-day | Day 13 of 15 | Probable causal (Naranjo 7) | Due ≤48h |
| AE-2026-0881 | Drug X (Helios-DRX) | QT prolongation, mild | Serious | MedWatch 15-day · EU MDR | Day 5 of 15 | Causality pending | In review |
| AE-2026-0880 | Drug Z (Helios-NEU) | Drowsiness, mild | Non-serious | Periodic (PSUR) | Q3 cycle | Probable causal | Complete |
| AE-2026-0879 | Drug Y (Helios-PRO) | Rash, moderate | Non-serious | Periodic (PSUR) | Q3 cycle | Possible causal | Complete |
| AE-2026-0878 | Drug X (Helios-DRX) | QT prolongation, moderate | Serious | MedWatch 15-day | Day 14 of 15 | Causality pending | Due ≤48h |
| AE-2026-0877 | Device D-7 (Helios-IMP) | Device migration, severe | Serious + Death-related | MedWatch 7-day · EU MDR · PMDA | Day 3 of 7 | Probable causal | 7-day expedited |
| AE-2026-0876 | Drug Y (Helios-PRO) | Nausea, mild | Non-serious | Periodic (PSUR) | Q3 cycle | Possible causal | Complete |
| AE-2026-0875 | Drug X (Helios-DRX) | Syncope, mild | Non-serious | Periodic (PSUR) | Q3 cycle | Possible causal | Complete |
Signal detection — 6 active patterns
Signal detection looks for disproportionate-reporting patterns that exceed FDA / EMA / PMDA thresholds. Six patterns currently active: QT-prolongation cluster on Drug X, hepatic-enzyme cluster on Drug Y, two 7-day expedited cases (device-migration death + Drug Y anaphylaxis unexpected), multi-regulator coordination need on AE-0877, causality assessment overdue on AE-0892.
5 cases for Drug X in 30 days
Drug X (Helios-DRX) has 5 QT-prolongation cases (AE-0892, 0890, 0887, 0881, 0878) reported in the last 30 days vs the 12-month rolling baseline of 1.3/month. The cluster crosses the FDA signal-of-disproportionate-reporting threshold. Initiate Health Authority Periodic Safety Update Report (PSUR) amendment workflow + consider Dear Healthcare Provider letter.
3 Drug Y cases, all probable causal
Drug Y (Helios-PRO) has 3 hepatic-enzyme-elevation cases (AE-0891, 0882, plus 1 from prior period), all with Naranjo 6+ probable causality. Reach Hy's Law threshold? Investigate co-medication patterns. EMA PRAC review may be triggered if pattern persists into Q4.
AE-2026-0877 Device D-7 migration
AE-2026-0877 is a serious + death-related device-migration event for Device D-7 (Helios-IMP). Triggers 7-day expedited reporting to FDA + EU MDR Article 87 + PMDA Article 68-10. Currently Day 3 of 7. Submission packets must include device-history record, root cause, and patient-impact narrative.
AE-2026-0886 Drug Y unexpected
AE-2026-0886 anaphylactic reaction is UNEXPECTED for Drug Y (not in current label). Per ICH E2D, unexpected + serious = 7-day expedited reporting. Day 1 of 7 — patient narrative + product-label-review packet due in 6 days.
AE-2026-0877 needs FDA + EU + PMDA
Device-migration death case requires concurrent submission to FDA (MedWatch + 21 CFR 803), EU notified body (EU MDR Art 87), and PMDA (Article 68-10). Submissions are NOT identical — each regulator expects a specific data shape. Coordinate via cross-region PV team to avoid contradictory narratives across packets.
AE-2026-0892 Day 12, causality pending
AE-2026-0892 (Drug X QT prolongation, severe) is on Day 12 of 15. Causality assessment is still pending — needs to be finalized within 48h to allow time for medical-writer + QA-review + submission. Auto-escalate to Drug Safety Director.
Regulator reporting routes
PV reporting is multi-regulator by default. Connected routes auto-submit via gateway APIs (FDA ESG, EVWEB, PMDA-J, EHR-OB). Manual routes (EU MDR Art 87 notified body) require email + signed PDF. Each route has its own data shape — submission via the wrong shape triggers rejection + resubmission delay.
| Regulator route | Status | Coverage | Last submission | Note |
|---|---|---|---|---|
| FDA (MedWatch 3500A) | Connected | ESG account active · 12 submissions this quarter | Last 4h ago | All accepted |
| FDA (MDR 21 CFR 803) | Connected | eMDR portal · 3 submissions this quarter | Last 8h ago | All accepted |
| EU EMA (EudraVigilance) | Connected | EVWEB account · 8 submissions this quarter | Last 6h ago | All accepted |
| EU Notified Body (EU MDR Art 87) | Active | Manual submission · 2 submissions this quarter | Last 3d ago | Email-based, manual |
| PMDA (Article 68-10) | Connected | PMDA-J portal · 4 submissions this quarter | Last 12h ago | All accepted |
| Health Canada (MedEffect) | Connected | EHR-OB API · 6 submissions this quarter | Last 1d ago | All accepted |
| TGA (Australia) | Connected | ARTG submission · 2 this quarter | Last 2d ago | All accepted |
| Periodic Safety Update Reports (PSUR) | In progress | Q3 2026 PSUR draft · 6 drugs | Internal review | Submit by 2026-08-15 |
PV audit chain
Every PV action (case intake, causality assessment, signal detection, expedited submission, deadline alert, PSUR cycle, regulator acknowledgement) is captured as a hash-chained event. The chain is the immutable evidence trail an FDA inspector or EMA auditor will eventually walk through.
Why this surface exists
Pharma PV teams are evaluated by inspectors on the full chain — case intake → coding → causality → seriousness → reportability → submission → regulator acknowledgement → PSUR cycle. The chain is the audit artifact. This surface compresses the typical week-by-week tracker spreadsheet into one operator board, with signal detection running across the same data.
Buyer: Pharma PV teams · Drug safety officers · Medical-device adverse-event committees · Sponsor QA · CRO PV staff.
Regulatory anchors: FDA 21 CFR 314.80 (MedWatch) · 21 CFR 803 (medical-device MDR) · EU Regulation 2017/745 (EU MDR) · ICH E2A-E2F · PMDA Article 68-10 · GVP Modules I-XVI.
KG Suite tie-back: Every operator decision on this surface emits an audit-stream event (hash-chained, ed25519-signable). Vault-contract data classification follows the Decision Card v0.3 pattern (data_vault_targets + retention_envelope). Incident escalations match the AI Incident Card profile shape. Evidence bundles align with the AI Evidence Format spec.
Static-only doctrine: No backend. No login. No telemetry. All synthetic data is baked into this HTML page as JavaScript constants. Nothing leaves the tab. Frame as readiness / evidence / posture / controls / scaffolding — never "compliant" or "certified" without an externally-attested audit.