Pharmacovigilance and Social Brand Safety Escalation Matrix

Role: Head of Global Pharmacovigilance and Healthcare Brand Safety

Context

• Monitored Product Name and Class: {{drug_product_name}}
• Social Listening Footprint: {{monitored_social_channels}}
• Mandatory Adverse Event Intake Window: {{adverse_event_intake_window}}
• Severity and Misinformation Tier: {{misinformation_severity_level}}
• Corporate Risk Tolerance: {{brand_risk_tolerance}}
• Cross-Functional Stakeholder Chain: {{stakeholder_escalation_paths}}

Task

Produce a rigorous Pharmacovigilance (PV) and brand safety social escalation matrix that defines intake, classification, regulatory reporting, and public response workflows for social media signals.

Method

1. Define ingestion criteria for potential Adverse Events (AEs) and product complaints across {{monitored_social_channels}}.
2. Establish the four minimum valid ICSR elements (identifiable patient, identifiable reporter, suspect product, adverse event) for {{drug_product_name}}.
3. Calibrate triage priority tiers based on {{adverse_event_intake_window}} and clinical severity.
4. Map misinformation narratives according to {{misinformation_severity_level}} to determine when public response vs. private containment is required.
5. Align cross-functional handoffs between social community managers, Medical Information, Regulatory Affairs, and {{stakeholder_escalation_paths}}.
6. Codify approved holding statements and dark-post containment protocols aligned with {{brand_risk_tolerance}}.
7. Construct the multi-tiered escalation matrix detailing trigger events, PV logging actions, legal review steps, and external response protocols.

Constraints

• MUST guarantee compliance with the mandatory PV intake timeline specified in {{adverse_event_intake_window}}.
• MUST NOT publish customized medical advice, unapproved off-label rebuttals, or non-standard corporate statements.
• All adverse event data handling MUST respect patient privacy and international data protection standards.
• The output MUST be formatted as a chronological severity escalation matrix.

Output format

Provide the deliverable in two mandatory parts:

1. Pharmacovigilance Intake Protocol (maximum 200 words defining identification, reconciliation, and audit trail rules).
2. Social Escalation and Response Matrix (markdown table containing columns: Risk Level, Event Trigger, PV Intake Action, Responsible Team from {{stakeholder_escalation_paths}}, SLA / Response Window, Public Action Protocol).

Self-review

• Ensure the 4 ICSR criteria are integrated into the primary intake evaluation step.
• Verify that the strict timelines in {{adverse_event_intake_window}} are maintained across all AE severity rows.
• Confirm clear distinction between scientific misinformation response and safety reporting intake.