Pharmacovigilance System Master File (PSMF)
SJ Pharma Consulting, LLC in Mendham, NJ has created a template for the pharmacovigilance system master file that fulfills the requirements of the new EU PV legislation. This is as specified in the GVP Module II of the EU Guideline on Good Pharmacovigilance Practices.
PSMF Table of Contents
| 1.0 Qualified Person Responsible for Pharmacovigilance (QPPV) | 4 | ||
| 1.1 | Name of EU QPPV | 4 | |
| 1.2 | Address of Site Where EU QPPV Is Based | 4 | |
| 1.3 | Curriculum Vitae and Description of Responsibilities of the EU QPPV | 5 | |
| 1.4 | Backup Procedure to Apply in the Absence of the EU QPPV | 5 | |
| 1.5 | Outside Office Hours | 5 | |
| 1.6 | Contact Persons for Pharmacovigilance at National Level | 6 | |
| 1.7 | Companies to Which This Pharmacovigilance System Master File Applies and for Which the EU QPPV Provides Services | 8 | |
| 2.0 Organizational Structure of the Marketing Authorization Holder | 10 | ||
| 2.1 | Company Structure and Operating Model for Pharmacovigilance | 10 | |
| 2.1.1 Company Profile | 10 | ||
| 2.1.2 Overview of Pharmacovigilance Management | 11 | ||
| 2.2 | Contractual Arrangements with other Persons and Organizations Involved in the Fulfillment of Pharmacovigilance Obligations | 15 | |
| 3.0 Sources of Safety Data | 18 | ||
| 3.1 | Inflow of ADRs and Safety Information | 18 | |
| 3.2 | Processing of ICSRs | 20 | |
| 3.3 | Outflow of Safety Data to EU Authorities | 22 | |
| 4.0 Computerized Systems and Databases | 22 | ||
| 4.1 | Validation and Maintenance | 22 | |
| 4.2 | Responsibility for the Operation of the Application and Its Location | 23 | |
| 4.3 | Backup and Failover | 23 | |
| 5.0 Pharmacovigilance Processes | 23 | ||
| 5.1 | Continuous Monitoring of Product Risk-Benefit Profile | 23 | |
| 5.2 | Risk Management System | 24 | |
| 5.3 | ICSR Collection, Collation, Follow-Up, Assessment, and Reporting | 25 | |
| 5.4 | PSUR Scheduling, Production, and Submission | 25 | |
| 5.5 | Communication of Safety Concerns | 26 | |
| 5.6 | Implementation of Safety Variations to the SmPC and PIL | 27 | |
| 6.0 Pharmacovigilance System Performance | 28 | ||
| 7.0 Quality System | 29 | ||
| 7.1 | General Overview | 29 | |
| 7.2 | Document and Record Control | 30 | |
| 7.3 | Procedural Documents | 31 | |
| 7.4 | Training | 31 | |
| 7.4.1 List of PharmaCo PV Locations in EU | 31 | ||
| 7.4.2 Summary Description of Training | 32 | ||
| 7.5 | Audits | 33 | |