Adverse Event Processing Workflow Chain Architecture

Role: Senior Pharmacovigilance Automation Architect

Context

• Intake sources: {{source_data_streams}}
• Target safety database: {{safety_database_target}}
• Regulatory reporting window: {{regulatory_reporting_window}}
• Human review threshold: {{human_review_threshold}}
• Coding dictionary standard: {{meddra_version}}
• Regulatory governance framework: {{compliance_framework}}

Task

Produce an architectural design report specifying an autonomous multi-agent workflow chain that ingests multi-channel clinical data, extracts adverse events, validates coding precision, and routes safety signals for human review.

Method

1. Map data ingress handlers across {{source_data_streams}} to normalize unstructured inputs into standardized intermediate payloads.
2. Define the entity extraction agent chain to isolate patient demographics, suspect drugs, concomitant medications, and adverse event descriptions.
3. Specify the semantic mapping agent that normalizes extracted symptom terms against {{meddra_version}} preferred terms with confidence scoring.
4. Design the seriousness and causality triage agent that evaluates outcomes against {{compliance_framework}} regulatory criteria.
5. Establish automated gating logic comparing agent confidence scores against {{human_review_threshold}} to determine straight-through processing versus mandatory human specialist triage.
6. Architect the fallback and exception-handling subsystem to protect the {{regulatory_reporting_window}} constraint against pipeline stalls.
7. Detail synchronization mechanisms and payload mapping for downstream integration into {{safety_database_target}}.

Constraints

• MUST maintain end-to-end data provenance tracking for each agent handoff.
• MUST NOT route any potential fatal or life-threatening case without human-in-the-loop signoff.
• All terminology mapping logic must cite confidence intervals and alternative codings.
• The report must address HIPAA, GxP, and FDA 21 CFR Part 11 requirements.

Output format

Deliver a formal technical report with the following structure:

• Executive Summary (max 200 words)
• Workflow Node Topology (step-by-step agent responsibilities and data schemas)
• Triage & Confidence Logic Matrix (tabular breakdown of routing triggers)
• Exception Handling & Escalation Framework
• Integration & Audit Trail Specification

Self-review

1. Does every agent step include clear input/output interfaces and failure fallbacks?
2. Are {{regulatory_reporting_window}} risk points explicitly mitigated in the exception architecture?
3. Is the transition between automated tagging and human review unambiguously defined?