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Pharmacovigilance System Master File (PSMF)
Rating: 4.1 out of 5(57 ratings)
198 students

Pharmacovigilance System Master File (PSMF)

Pharmacovigilance System Master File, PSMF, Logbook, QPPV, Qualified Person Responsible for Pharmacovigilance
Created byPV Drug Safety Academy
Last updated 5/2026
English
English [Auto],

What you'll learn

  • Legal requirements for PSMF
  • Objectives of PSMF
  • Registration and Maintenance of PSMF
  • Sections of PSMF
  • Change control, Logbook, versions and Archival of PSMF
  • PSMF Annexures

Course content

6 sections • 8 lectures • 1h 33m total length

  • Introduction and Legal Requirements9:23

    The pharmacovigilance system master file, or PSMF, is a central, detailed safety system; this lecture covers its scope, structure, and EU legal requirements.

  • Objectives and Need of PSMF8:47

    Explain the objectives of the pharmacovigilance system master file. Emphasize compliance, documentation, transparency, risk management, adverse event reporting, signal detection, and need for PSMF in registrations, renewals, and inspections.

  • Quiz

Requirements

  • Basic Level of English
  • Good quality of Internet connection
  • Desktop, Laptop or Smartphone

Description

Course Title: Pharmacovigilance System Master File (PSMF)

____________________________________________________________________________________________________

This course of Pharmacovigilance System Master File (PSMF) is exclusively designed for Pharmacovigilance professionals, Pharma students, Medical practitioners and Life science graduates.

This course will be helpful to those who have ICSR, Aggregate Reporting, Signal management or Risk management experience in Pharmacovigilance domain and for those who wants to learn and pursue their career in maintaining Pharmacovigilance System Master File (PSMF).


This is one of the high paying Job Role in Pharmacovigilance domain.


Pharmacovigilance System Master File (PSMF) is complex but challenging job role in Pharmacovigilance domain.

The Trainer of this course has more than 11+ years of Pharmacovigilance Industry Experience from different multinational companies (MNC). He has expertise in ICSR, Aggregate Reports, Signal and Risk Management.

In this course we have covered following topics:


  • Legal requirements and need of PSMF

  • Registration and Maintenance of PSMF

  • Representation of Pharmacovigilance Systems

  • Sections of PSMF:

    - QPPV

    - Organisational structure of the MAH

    - Sources of safety data

    - Computerised Systems and Databases

    - Pharmacovigilance Processes

    - Pharmacovigilance System Performance

    - Quality System

    - Annexures

  • Change control, Logbook, Versions and Archival

  • PSMF presentation - Format and Layout

By completing this course, you will get to know about "Best practices of Pharmacovigilance System Master File (PSMF)".


Enroll and join us in this exciting course. See you soon in the class.


Best Regards,

PV Drug Safety Academy

Who this course is for:

  • Pharmacovigilance Experienced candidates
  • Graduate or Postgraduate degree in Pharmacy (e.g., B Pharm, M Pharm, M S Pharm, Pharm D)
  • Graduate or Postgraduate degree in Life Sciences (BSc, MSc, PhD)

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