{
  "id": "workflow:pharmacovigilance-signal-detection",
  "_kind": "Workflow",
  "_file": "workflows/workflows/workflows-pharma.yaml",
  "_cluster": "workflows",
  "attributes": {
    "displayName": "Pharmacovigilance Signal Detection",
    "workflowKind": "operational",
    "triggerType": "scheduled",
    "typicalCadence": "weekly",
    "complexity": "cross-team",
    "description": "Detects and evaluates safety signals from post-market drug surveillance\n-- ingesting adverse event reports from FAERS, EudraVigilance, and\nspontaneous reporting systems, running disproportionality analysis (PRR,\nROR, BCPNN) to identify statistically elevated drug-event combinations,\ntriaging signals by clinical seriousness and novelty, correlating\nfindings with published literature and clinical trial safety databases,\nand escalating confirmed signals to safety evaluation boards. Produces\nsignal detection reports, cumulative review summaries, and PADER/PSUR\ncontributions. Excludes benefit-risk assessment decisions.\n"
  },
  "outgoingEdges": [
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "role:data-scientist",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "role:incident-commander",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "role:security-reviewer",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "skill-area:python-data-pipelines",
      "kind": "requires_skill_area",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "skill-area:observability-pipeline",
      "kind": "requires_skill_area",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "domain:pharmaceuticals",
      "kind": "applies_to_domain",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "domain:data-engineering",
      "kind": "applies_to_domain",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "responsibility:data-quality-monitoring",
      "kind": "triggers_responsibility",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "responsibility:run-security-scans",
      "kind": "triggers_responsibility",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "org-unit:compliance-team",
      "kind": "performed_by_org_unit",
      "attributes": {}
    },
    {
      "from": "workflow:pharmacovigilance-signal-detection",
      "to": "org-unit:data-team",
      "kind": "performed_by_org_unit",
      "attributes": {}
    }
  ],
  "incomingEdges": []
}