Document Description
PSMF template suite contain comprehensive content examples you can adapt as needed in standard tools like Word or PowerPoint.
Main section document templates (word)
- Section I – Qualified Person Responsible for Pharmacovigilance
- Section II – Organisational Structure of Marketing Authorization Holder
- Section III – Sources of Safety Data
- Section IV – Computerized Systems and Databases
- Section V – Pharmacovigilance Processes
- Section VI – Pharmacovigilance System Performance
- Section VII – Quality System
Annexes templates (word)
- Annex A – Qualified Person Responsible for Pharmacovigilance
- Annex B – Organisational Structure of Marketing Authorization Holder
- Annex C – Sources of Safety Data
- Annex D – Computerized Systems and Databases
- Annex E – Pharmacovigilance Processes
- Annex F – Pharmacovigilance System Performance
- Annex G – Quality System
- Annex H – Products
- Annex I – PSMF Revision Log
PSMF Standard Operating Procedure
Kick-off meeting, internal presentation sample template
SPS document 1.8.1 sample template
