Pharmacovigilance Medical Inquiry and Safety Email Protocol Specification

Role: Head of Medical Information Operations and Global Pharmacovigilance Quality Systems.

Context

• Product Portfolio: {{product_portfolio}}
• Customer Segment: {{customer_segment_type}}
• Pharmacovigilance Triage SLA: {{pharmacovigilance_sla}}
• Safety Reporting Mandates: {{safety_reporting_regulations}}
• Ticketing Platform: {{crm_ticketing_system}}
• Escalation Hierarchy: {{escalation_tier_structure}}

Task

Draft a technical and operational specification for an inbound and outbound customer email system that processes unsolicited medical inquiries, accurately identifies Potential Adverse Events (PAEs), and issues compliant, medically reviewed responses.

Method

1. Define natural language processing (NLP) keyword and intent classification criteria inside {{crm_ticketing_system}} to detect adverse events and product quality complaints.
2. Map routing and auto-acknowledgment logic enforcing {{pharmacovigilance_sla}} response windows.
3. Structure modular email response templates for three distinct scenarios: Standard Medical Information Request, Suspected Adverse Event Follow-up, and Off-Label Inquiry Boundary Statement.
4. Detail required fields for safety intake (identifiable patient, identifiable reporter, suspect product, adverse event).
5. Embed dynamic reference citations, fair-balance statements, and approved product labeling disclaimers tailored to {{customer_segment_type}}.
6. Formulate fallback and secondary contact workflows for critical safety escalations per {{escalation_tier_structure}}.
7. Detail audit trail logging requirements to satisfy {{safety_reporting_regulations}} inspection standards.

Constraints

• MUST trigger mandatory pharmacovigilance logging within defined {{pharmacovigilance_sla}} upon detection of any potential safety event.
• MUST NOT provide off-label guidance or unsolicited commercial information under any condition.
• Auto-acknowledgment emails must never validate causal product liability while expressing professional diligence.
• Response templates must explicitly incorporate approved Summary of Product Characteristics (SmPC) or Prescribing Information (PI) links.

Output format

Present the specification following this exact structure:

1. System Triage & Routing Architecture (logic rules, NLP trigger lists, SLA timers).
2. Standard Response Template Specifications (3 complete email models with token mappings and disclaimers).
3. Regulatory Compliance & Audit Controls under {{safety_reporting_regulations}}.
4. Escalation Workflow & Case Reconciliation Procedures. Word count should fall between 900 and 1,300 words.

Self-review

• Does the triage logic strictly satisfy {{pharmacovigilance_sla}} turnaround constraints?
• Are four minimum criteria for valid adverse event reporting systematically captured in follow-up forms?
• Are off-label boundary statements legally and medically unambiguous for {{customer_segment_type}}?