How to Write a Pharmacovigilance System Master File
Describe the pharmacovigilance system you actually operate, in a form an inspector can test.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
The Pharmacovigilance System Master File (PSMF) is the standing description of the system a marketing authorisation holder uses to monitor the safety of its authorised products. It is not a policy document and not a brochure: every statement in it is a claim an inspector can walk into your organisation and test. The failure mode is a PSMF that describes an aspirational system rather than the operating one.
- 1
Describe the system, not the intention
Document the pharmacovigilance system as it currently operates — the structures, processes, responsibilities and resources actually in use. Where a process is in transition, say so and give the date it changes. An accurate description of an imperfect system is defensible; an idealised one is a finding in every section it touches.
- 2
Name the qualified person and make the role real
Identify the qualified person responsible for pharmacovigilance, their contact details, and the arrangements for permanent availability. Describe the deputy arrangement and how the role is exercised in practice, including the authority to act on safety concerns.
- 3
Map the organisational structure and delegated activities
Set out the organisation, the sites where pharmacovigilance activities are performed, and every activity delegated to a third party. Delegation is permitted; undocumented delegation is not, and an activity performed somewhere the PSMF does not name is the kind of gap an inspection is designed to find.
- 4
Document the safety database and its computerised systems
Describe the systems used for case management, signal detection and periodic reporting, including their location, their validated status, and the arrangements for business continuity. State how data flows between systems rather than merely listing them.
- 5
Set out the quality system and its performance
Describe the written procedures, training, record management, and the metrics used to monitor pharmacovigilance performance and compliance. Include how deviations are captured and corrected — an inspector reads this section as a claim about self-awareness.
- 6
Maintain the logbook of changes
Keep the annex recording changes to the master file current as the system changes, not retrospectively before an inspection. The logbook is the evidence that the document tracks reality; a burst of entries dated the week before an inspection says the opposite.
- !A master file describing the target-state system rather than the one operating today.
- !Delegated activities performed at a site or by a partner the master file never names.
- !The change logbook updated in a single retrospective burst rather than as changes occur.
- !Annexes maintained by different owners that contradict the main body on who does what.
How to Write a Pharmacovigilance System Master File: frequently asked questions
Common questions on write a pharmacovigilance system master file.
Is the master file a regulatory submission or an internal document?
It is a standing description of the system that must be kept current and made available to the competent authority on request, and at inspection. Treat it as permanently inspectable rather than as something assembled for a submission window — its value is that it is true on any given day.
How current does it have to be?
Current enough that it describes the system in operation now. Substantive changes to structures, responsibilities, systems or delegated activities belong in the document and its change logbook as they happen, because the logbook is the evidence that the description tracks the real system.
Can pharmacovigilance activities be delegated to a third party?
Yes, and it is common. What cannot be delegated is accountability: the marketing authorisation holder remains responsible, the arrangement must be documented in the master file, and the oversight of the delegate has to be evidenced rather than asserted.