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
1.1Name of EU QPPV4
1.2Address of Site Where EU QPPV Is Based4
1.3Curriculum Vitae and Description of Responsibilities of the EU QPPV5
1.4Backup Procedure to Apply in the Absence of the EU QPPV5
1.5Outside Office Hours5
1.6Contact Persons for Pharmacovigilance at National Level6
1.7Companies to Which This Pharmacovigilance System Master File Applies and for Which the EU QPPV Provides Services8
2.0 Organizational Structure of the Marketing Authorization Holder10
2.1Company Structure and Operating Model for Pharmacovigilance10
2.1.1 Company Profile10
2.1.2 Overview of Pharmacovigilance Management11
2.2Contractual Arrangements with other Persons and Organizations Involved in the Fulfillment of Pharmacovigilance Obligations15
3.0 Sources of Safety Data18
3.1Inflow of ADRs and Safety Information18
3.2Processing of ICSRs20
3.3Outflow of Safety Data to EU Authorities22
4.0 Computerized Systems and Databases 22
4.1Validation and Maintenance22
4.2Responsibility for the Operation of the Application and Its Location23
4.3Backup and Failover23
5.0 Pharmacovigilance Processes23
5.1Continuous Monitoring of Product Risk-Benefit Profile23
5.2Risk Management System24
5.3ICSR Collection, Collation, Follow-Up, Assessment, and Reporting25
5.4PSUR Scheduling, Production, and Submission25
5.5Communication of Safety Concerns26
5.6Implementation of Safety Variations to the SmPC and PIL27
6.0 Pharmacovigilance System Performance28
7.0 Quality System29
7.1General Overview29
7.2Document and Record Control30
7.3Procedural Documents31
7.4Training31
7.4.1 List of PharmaCo PV Locations in EU31
7.4.2 Summary Description of Training32
7.5Audits33