PV SOP Development

Overview

Standard Operating Procedures (SOPs) are essential for ensuring that pharmacovigilance activities are performed consistently, traceably, and in accordance with defined responsibilities and applicable requirements.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders, pharmaceutical companies, CROs, and other life-sciences organizations with development, review, revision, harmonization, and implementation support for pharmacovigilance SOPs and associated controlled documents.

Our approach focuses on creating SOPs that are operationally practical, clearly written, role-specific, traceable, and aligned with the actual pharmacovigilance system rather than relying on generic templates.

Our PV SOP Services

SOP Development

Preparation of new pharmacovigilance SOPs based on the organization’s products, processes, systems, business model, and assigned responsibilities.

SOP Review & Gap Assessment

Detailed review of existing SOPs to identify missing activities, unclear roles, inconsistent workflows, outdated references, or gaps between documented procedures and actual practice.

SOP Revision & Harmonization

Revision of existing procedures to improve consistency across related PV processes and eliminate duplication, conflict, or ambiguity.

Process Mapping

Development of clear process flows showing how safety information moves between functions, systems, partners, and regulatory reporting pathways.

Roles & Responsibilities Definition

Clarification of responsibilities for:

• MAH
• PVOIC / responsible PV personnel
• PV operations
• Medical reviewers
• Quality reviewers
• Regulatory teams
• Database administrators
• Business partners
• Vendors and service providers

SOP Implementation Support

Support for controlled rollout of finalized SOPs through training, effective-date management, acknowledgment, and implementation tracking.

Annexure & Template Development

Preparation of practical supporting forms, logs, trackers, checklists, and templates used during routine PV activities.

SOP Periodic Review

Support for periodic review and update of SOPs based on process changes, system changes, audit findings, regulatory developments, or organizational changes.

PV SOPs We Can Support

Depending on scope, MGS can develop or review SOPs covering:

• ICSR receipt and case intake
• Case validity assessment
• Case processing
• Quality review
• Medical review
• Follow-up management
• Regulatory reporting
• Literature monitoring
• Signal management
• Aggregate reporting
• Risk management
• Safety database management
• MedDRA management
• Duplicate management
• Pregnancy and breastfeeding exposure
• Special situations
• Product complaints with safety information
• SDEA / PVA management
• Reconciliation
• PSMF management
• Training
• Deviation management
• CAPA
• Change control
• PV documentation
• Record retention and archival
• PV audit readiness
• Business continuity
• Inspection management
• Vendor oversight

Key SOP Components

MGS may structure SOPs to include:

• Purpose
• Scope
• Definitions
• Roles and responsibilities
• Procedure
• Process timelines
• Escalation requirements
• Documentation requirements
• Quality checks
• Associated records
• Forms and annexures
• Training requirements
• References
• Revision history
• Related procedures

Our Approach

• Understand the PV System

Review products, responsibilities, workflows, systems, partners, agreements, and current practices.

• Identify Required SOPs

Define the SOP inventory needed to adequately cover the pharmacovigilance system.

• Map the Process

Understand how each activity is actually performed and where handoffs, reviews, and escalation points occur.

• Draft

Prepare clear and practical procedures aligned with actual responsibilities and operating workflows.

• Review & Finalize

Incorporate stakeholder comments, confirm consistency across related SOPs, and finalize controlled documents.

• Implement & Maintain

Support training, effective-date management, periodic review, revision, and change control.

Typical Deliverables

Depending on scope, MGS can provide:

• PV SOP master list
• SOP gap-assessment report
• Draft SOPs
• Revised SOPs
• Work instructions
• Process flowcharts
• Roles and responsibilities matrix
• Annexures
• Checklists
• Forms
• Logs
• Trackers
• Training materials
• SOP review tracker
• Change-history documentation
• Implementation support

Why Choose MGS

Operationally Practical SOPs

MGS develops procedures that reflect how pharmacovigilance activities are actually performed.

Integrated PV Perspective

Our SOPs can align case management, literature, signal management, aggregate reporting, database activities, agreements, quality systems, and training.

Clear Responsibility Definition

Roles and handoffs are clearly described to reduce ambiguity and operational gaps.

Consistent Documentation

Related SOPs, templates, logs, and annexures can be harmonized within one controlled PV framework.

Lifecycle Support

MGS can support initial SOP development, periodic review, revision, implementation, and remediation.

Who We Support

MGS can provide PV SOP Development support for:

• Marketing Authorization Holders
• Pharmaceutical companies
• Biopharmaceutical organizations
• CROs
• Generic-drug companies
• Product-license partners
• Organizations establishing a new PV system
• Organizations expanding or remediating existing PV procedures
• Companies preparing for PV audits or inspections