Pharmacovigilance Adverse Event Signal Triage Workflow Plan

Role: Director of Safety Systems and Regulatory Pharmacovigilance Engineering.

Context

• Target Safety Database: {{safety_database_type}}
• Source Intake Streams: {{intake_data_channels}}
• Terminology Standard: {{meddra_version}}
• Compliance Timeline SLA: {{reporting_timeline_sla}}
• Automated Triage Confidence Threshold: {{confidence_threshold_score}}
• Audit Requirement: {{audit_trail_requirements}}

Task

Produce an operational systems report detailing a multi-agent workflow chain that ingests multi-channel adverse event narratives, validates minimum safety criteria, maps terms using {{meddra_version}}, and routes prioritized cases to {{safety_database_type}} within {{reporting_timeline_sla}}.

Method

1. Define the ingestion agent architecture capable of standardizing text across {{intake_data_channels}}.
2. Design the ICSR Four-Element verification agent (identifiable patient, identifiable reporter, suspect product, adverse event).
3. Detail the semantic extraction and MedDRA coding agent for mapping narrative symptoms against {{meddra_version}} preferred terms.
4. Specify the seriousness evaluation agent to flag expedited fatal, life-threatening, or disabling events.
5. Construct the dynamic routing agent that directs cases meeting {{confidence_threshold_score}} directly to draft case creation in {{safety_database_type}}.
6. Formulate fallback mechanisms for low-confidence or ambiguous events requiring immediate safety specialist triage.
7. Establish timing monitors to ensure safety cases do not breach the mandated {{reporting_timeline_sla}}.
8. Specify the logging agent configuration to satisfy {{audit_trail_requirements}} across all agent transitions.

Constraints

• MUST flag potential 7-day and 15-day expedited reports within the first execution step.
• MUST NOT commit fully automated case submissions without human validation if confidence falls below {{confidence_threshold_score}}.
• Intermediate agent reasoning states MUST remain fully auditable under {{audit_trail_requirements}}.
• Architecture must support simultaneous ingest from all defined {{intake_data_channels}}.

Output format

Present a technical workflow plan structured into:

1. Ingestion Pipeline & Channel Normalization
2. Four-Criteria Validation & MedDRA Agent Logic
3. Triage Routing, SLA Monitoring, & Escalation
4. Compliance Architecture & Verification Log Limit the document to 800-1,200 words.

Self-review

• Does the workflow cover ICSR four-element validation comprehensively?
• Is the threshold {{confidence_threshold_score}} clearly applied as a decision boundary?
• Are strict timelines enforced for {{reporting_timeline_sla}} alerts?