PSMF Support

Overview

The Pharmacovigilance System Master File (PSMF) provides a structured description of an organization’s pharmacovigilance system, including governance, responsibilities, processes, quality controls, safety-data sources, computerized systems, performance monitoring, and supporting documentation.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders and other life-sciences organizations with PSMF preparation, review, maintenance, gap assessment, annexure management, and lifecycle updates.

Our approach focuses on ensuring that the PSMF accurately reflects the actual pharmacovigilance system in operation, including organizational responsibilities, outsourced activities, safety-data flow, quality oversight, agreements, training, computerized systems, and compliance monitoring.

Our PSMF Services

PSMF Development

Preparation of a new PSMF based on the organization’s pharmacovigilance structure, products, processes, systems, partners, and applicable requirements.

PSMF Review & Gap Assessment

Review of existing PSMF to identify missing, outdated, inconsistent, or inadequately described information.

PV System Description

Documentation of the overall pharmacovigilance system, including governance, responsibilities, operational processes, interfaces, and oversight arrangements.

Organizational Structure Support

Development and review of pharmacovigilance organizational charts, functional responsibilities, reporting lines, and key roles.

PVOIC / Responsible PV Contact Documentation

Support for documenting applicable pharmacovigilance oversight roles, responsibilities, contact details, backup arrangements, and governance.

Safety Data Flow Documentation

Mapping of how safety information is received, processed, reviewed, exchanged, reported, reconciled, and archived.

Outsourced PV Activity Documentation

Documentation of CROs, vendors, business partners, and other third parties performing pharmacovigilance activities on behalf of the organization.

Safety Database Documentation

Description of computerized systems and safety databases used for case processing, reporting, tracking, or other PV activities.

Quality System Documentation

Support for describing:

• PV SOP framework
• Training system
• Deviation management
• CAPA
• Change control
• Quality review
• Compliance monitoring
• Audit activities
• Inspection readiness

PSMF Annexure Management

Preparation and maintenance of annexures, lists, inventories, and supporting records referenced within the PSMF.

PSMF Maintenance & Updates

Support for updates following organizational changes, new products, new agreements, system changes, vendor changes, procedural updates, or regulatory developments.

Key PSMF Content Areas

Depending on applicable requirements and the organization’s PV system, MGS may support documentation of:

• Pharmacovigilance organization
• Responsible PV personnel
• Roles and responsibilities
• Product portfolio
• Sources of safety data
• ICSR management
• Literature monitoring
• Signal management
• Aggregate reporting
• Risk-management activities
• Regulatory reporting
• Safety database
• Computerized systems
• SDEA / PVA arrangements
• Outsourced activities
• SOPs
• Training
• Quality system
• Deviations and CAPA
• Compliance monitoring
• Performance indicators
• Audits
• Inspection history
• Record management
• Archival
• Business continuity
• Annexures and supporting documentation

Typical PSMF Annexures

Depending on the applicable framework, supporting annexures may include:

• Product lists
• PV contact details
• Organizational charts
• Safety database information
• SOP lists
• Agreement lists
• Outsourced activity lists
• Training records or training-system references
• Audit schedules or audit information
• Performance indicators
• Compliance metrics
• System inventories
• Other supporting PV-system records

Our Approach

• Understand the PV System

Review the organization, products, responsibilities, partners, processes, systems, and existing documentation.

• Map the System

Document PV activities, safety-data flows, interfaces, outsourced functions, and governance arrangements.

• Assess Gaps

Compare current documentation and actual practices to identify missing, outdated, or inconsistent information.

• Develop or Update

Prepare the PSMF and associated annexures based on the current operating model.

• Review & Reconcile

Cross-check the PSMF against SOPs, agreements, organizational charts, system records, product lists, and operational practices.

• Maintain

Support controlled updates when the pharmacovigilance system, products, personnel, systems, or responsibilities change.

Typical Deliverables

Depending on scope, MGS can provide:

• PSMF draft
• PSMF gap-assessment report
• PSMF update
• PV organizational chart
• Roles and responsibilities matrix
• Safety-data flow diagram
• Product list annexure
• Contact-person annexure
• SOP inventory
• SDEA / PVA inventory
• Vendor and outsourced-activity list
• Safety-system inventory
• PSMF annexures
• Change tracker
• Periodic-review checklist
• Inspection-readiness support

Why Choose MGS

Operational PV Understanding

MGS develops PSMF content based on how pharmacovigilance activities are actually performed, not simply as a generic document template.

System-Wide Perspective

Our approach links case management, literature, signals, aggregate reporting, agreements, databases, quality systems, and training.

Documentation Consistency

PSMF information can be cross-checked against SOPs, agreements, product lists, organization charts, and operational records.

Lifecycle Maintenance

MGS can support both initial PSMF development and ongoing updates as the PV system evolves.

Inspection-Ready Focus

Our emphasis is on maintaining a clear, current, traceable, and supportable description of the pharmacovigilance system.

Who We Support

MGS can provide PSMF support for:

• Marketing Authorization Holders
• Pharmaceutical companies
• Biopharmaceutical organizations
• Generic-drug companies
• Companies establishing a new PV system
• Organizations outsourcing selected PV activities
• Organizations updating or remediating existing PSMF

Companies preparing for PV audits or inspections