Pharmacovigilance Adverse Event Intake and Triage Workflow Plan

Role: Principal Pharmacovigilance Automation Architect with 15+ years designing GxP-compliant safety reporting pipelines.

Context

• Life sciences sponsor: {{sponsor_name}}
• Therapeutic focus area: {{therapeutic_area}}
• Ingestion channels to support: {{ingestion_channels}}
• Primary regulatory authority: {{regulatory_agency}}
• Compliance and validation standard: {{validation_framework}}
• Human review trigger threshold: {{human_oversight_threshold}}

Task

Develop a comprehensive architectural workflow plan that orchestrates an autonomous multi-agent chain for adverse event intake, source document parsing, MedDRA coding, seriousness evaluation, and compliant case routing.

Method

1. Map multi-channel intake handlers across {{ingestion_channels}} to standardize unstructured narrative text into structured case payloads.
2. Design the medical entity extraction sub-agent to isolate patient demographics, suspect medications, dosages, and adverse event terms.
3. Define the MedDRA auto-coding agent logic, incorporating semantic similarity scoring, synonym tables, and strict confidence thresholds.
4. Construct the seriousness and causality assessment agent to evaluate 7-day and 15-day expedited reporting criteria under {{regulatory_agency}} guidelines.
5. Establish duplicate detection and case reconciliation rules against existing safety database records.
6. Specify the deterministic routing matrix that triggers human-in-the-loop review whenever confidence falls below {{human_oversight_threshold}} or when fatal/life-threatening outcomes occur.
7. Detail the audit logging, data lineage tracking, and validation protocols required to satisfy {{validation_framework}}.

Constraints

• MUST maintain strict 21 CFR Part 11 and GxP data integrity standards with immutable event logging.
• MUST NOT route any potential expedited adverse event to auto-submission without a mandatory qualified person safety review.
• Agent handoffs must implement deterministic retry logic and dead-letter queues for unparseable input payloads.
• All terminology mappings must explicitly reference standard MedDRA hierarchy levels (SOC, HLGT, HLT, PT, LLT).

Output format

• Phase 1: Ingestion & Extraction Architecture (max 250 words)
• Phase 2: Agent Handoff & Logic Specifications (4-step detailed breakdown)
• Phase 3: Triage Matrix & Human Escalation Rules (table format with 4 columns: Trigger, Severity, Agent Action, Human Role)
• Phase 4: Regulatory Compliance & Audit Controls (max 200 words)

Self-review

• Ensure all channels in {{ingestion_channels}} have dedicated parsing and sanitization steps.
• Confirm the human-in-the-loop threshold matches {{human_oversight_threshold}} exactly.
• Verify the triage workflow adheres strictly to the timeline requirements of {{regulatory_agency}}.