Medical E-Commerce Pharmacovigilance and Review Moderation Plan

Role: Principal Healthcare Compliance Director & E-Commerce Operations Lead

Context

• Regulated product classification: {{health_product_category}}
• Adverse event and side-effect escalation protocol: {{adverse_event_protocol}}
• Review capture and sentiment tech stack: {{moderation_tech_stack}}
• Regulatory governance body and rules: {{jurisdiction_framework}}
• Active consumer review touchpoints: {{review_channels}}
• Mandated incident escalation window: {{escalation_timeline}}

Task

Develop an actionable operational plan to integrate mandatory adverse event detection, compliance tagging, and customer support escalation into the consumer review moderation pipeline for {{health_product_category}} under {{jurisdiction_framework}} requirements.

Method

1. Map all ingestion channels across {{review_channels}} into the centralized {{moderation_tech_stack}} intake queue.
2. Establish an automated medical-lexicon keyword matrix to tag potential adverse events, off-label usage claims, and critical safety signals.
3. Design a triage rubric categorizing UGC into standard product feedback, medical inquiries, and formal adverse events requiring {{adverse_event_protocol}} invocation.
4. Define exact cross-functional routing between e-commerce customer care, quality assurance, and medical safety teams within {{escalation_timeline}}.
5. Draft standardized, empathetic, non-promotional public response scripts that satisfy {{jurisdiction_framework}} disclosure requirements while inviting private clinical follow-up.
6. Formulate clear publication criteria distinguishing lawful negative consumer reviews from legally actionable non-compliant health claims.
7. Establish permanent audit-logging protocols and recurring regulatory reporting cadence for flagged user submissions.

Constraints

• MUST strictly maintain patient privacy and comply with relevant health data protection laws.
• MUST NOT suppress or delete authentic negative product efficacy reviews that contain no safety violations or defamatory claims.
• All adverse event escalations MUST execute within the verified bounds of {{escalation_timeline}}.
• Response templates MUST avoid establishing formal doctor-patient relationships or prescribing medical advice.

Output format

• Phase-based operational rollout plan across 4 chronological execution stages
• Adverse Event Triage Matrix (Markdown table: Trigger Keyword Class, Risk Level, Action, Responsible Owner, SLA)
• Standardized Customer Care Response Playbook (3 distinct scenarios)
• Regulatory Audit & Logging Protocol (max 300 words)

Self-review

• Verifies that adverse event reporting triggers match {{adverse_event_protocol}}.
• Confirms non-suppression principles for legitimate critical reviews are explicitly safeguarded.
• Ensures all operational SLAs fit within {{escalation_timeline}}.