Pharmacovigilance

Pharmacovigilance System Master File (PSMF)

The Pharmacovigilance System Master File (PSMF) describes the PV system for EU and related markets. Viltis helps structure, maintain, and inspect-ready the PSMF and linked annexes.

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Practice areaPharmacovigilance
Typical needCapability support for regulated programs
EngagementConsulting, augmentation, or hybrid
Related pathPharmacovigilance

The client situation

When organizations typically need this capability.
  • First PSMF establishment
  • Inspection findings on PSMF quality
  • Organizational change requiring PSMF updates

How Viltis helps

Structured support, end to end

  1. 01

    Step 1

    PSMF structure design

  2. 02

    Step 2

    Annex maintenance processes

  3. 03

    Step 3

    Cross-functional data gathering

  4. 04

    Step 4

    Inspection rehearsal

The Pharmacovigilance System Master File (PSMF) describes the PV system for EU and related markets. Viltis helps structure, maintain, and inspect-ready the PSMF and linked annexes.

Typical deliverables

What engagement can produce

PSMF core and annexes

Update SOPs

Inspection packs

FAQ

Common questions

Can you act as QPPV?

QPPV services are available through Viltis PV offerings when contractual and regulatory conditions are met.

Related proof

Manufacturing, Quality and Process Team

Recommissioning and qualifying a manufacturing site to produce COVID-19 test kits at scale.

Read the case study →

Viltis provides consulting and resourcing for compliance readiness and operational support. We do not issue certifications or act as an accredited certification body.

Need support with Pharmacovigilance System Master File (PSMF)?

Discuss this requirement with our team - scope, timeline, and delivery model.

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