Design a scalable, compliant pharmacovigilance operating model that strengthens safety oversight and operational performance.
Table of Contents
Chapter 1. Pharmacovigilance Operating Model Foundations
1.1 The Purpose and Scope of Pharmacovigilance
1.2 Global, Regional, and Local PV Responsibilities
1.3 The PV Operating Model: Processes, Roles, Systems, and Governance
1.4 Common PV Failure Modes and Risk Indicators
1.5 PV Operating Model Maturity Diagnostic
Chapter 2. Case Intake, Triage, and Source Management
2.1 Adverse Event Sources and Reporting Channels
2.2 Intake Requirements, Minimum Criteria, and Day-Zero Rules
2.3 Triage of Serious, Non-Serious, Special Situation, and Product Quality Cases
2.4 Intake Forms, Scripts, Mailboxes, Portals, and Contact Centers
2.5 Case Intake Checklist and Escalation Template
Chapter 3. Case Processing and Safety Database Workflow
3.1 End-to-End ICSR Processing Workflow
3.2 Case Data Entry, Coding, Narrative Writing, and Medical Review
3.3 Duplicate Detection, Follow-Up, and Case Versioning
3.4 Regulatory Submission Rules and Workflow Controls
3.5 Safety Database Workflow Design Template
Chapter 4. PV Systems, Data, and Technology Enablement
4.1 Safety Database Requirements and System Ownership
4.2 Case Workflow Configuration and User Roles
4.3 Interfaces With Clinical, Medical Information, Quality, and Regulatory Systems
4.4 Data Quality, Reconciliation, Audit Trails, and Access Controls
4.5 Technology Roadmap and Validation Considerations
Chapter 5. PV Quality System, SOP Set, and Training Model
5.1 PV Quality System Architecture
5.2 Core SOPs, Work Instructions, and Job Aids
5.3 Training, Role Qualification, and Compliance Tracking
5.4 Deviation, CAPA, Change Control, and Inspection Readiness
5.5 SOP Gap Assessment Checklist
Chapter 6. PV Agreements, Vendors, and Partner Oversight
6.1 When PV Agreements Are Required
6.2 Safety Data Exchange Agreements and Responsibilities
6.3 CRO, Distributor, License Partner, and Service Provider Oversight
6.4 Reconciliation, Compliance Monitoring, and Issue Escalation
6.5 PV Agreement Review Checklist
Chapter 7. Governance, KPIs, and Continuous Improvement
7.1 PV Governance Forums and Decision Rights
7.2 Operational KPIs for Case Processing and Submissions
7.3 Quality KPIs, Compliance Metrics, and Inspection Signals
7.4 Management Review, Trend Analysis, and Improvement Planning
7.5 PV Dashboard and KPI Pack Template
Chapter 8. External Support Options for PV Operating Model Projects
8.1 When to Engage External PV Support
8.2 Support From Large Consulting Firms
8.3 Specialist PV Vendors, CROs, and Technology Providers
8.4 Independent Management Consultants Through Umbrex
8.5 Advisor Selection Checklist and Engagement Model
