PV Training

Overview

Effective pharmacovigilance depends on knowledgeable personnel who understand their responsibilities, reporting timelines, safety processes, documentation requirements, and escalation pathways.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders, pharmaceutical companies, CROs, and other life-sciences organizations with structured pharmacovigilance training for new joiners, operational teams, quality personnel, medical reviewers, business partners, and management.

Our approach combines regulatory expectations, practical workflows, case-based learning, SOP requirements, quality principles, and real-world PV scenarios to help participants understand not only what to do, but also why each activity matters.

Our PV Training Services

Pharmacovigilance Fundamentals

Training on core PV concepts such as adverse events, adverse drug reactions, seriousness, severity, causality, expectedness, listedness, reportability, and basic safety-system principles.

ICSR Case Processing Training

Practical training covering:

• Case intake
• Validity assessment
• Duplicate search
• Data entry
• MedDRA coding
• Drug coding
• Seriousness assessment
• Expectedness / listedness
• Causality
• Narrative writing
• Follow-up
• Case closure

Quality Review Training

Training for reviewers on case completeness, consistency, medical logic, coding, chronology, regulatory fields, documentation quality, and error identification.

Medical Review Training

Training on medical assessment of ICSRs, causality, clinical interpretation, dechallenge, rechallenge, seriousness, expectedness, and documentation of medical rationale.

Regulatory Safety Reporting Training

Training on reporting pathways, timelines, submission responsibilities, case formats, acknowledgments, and reporting documentation.

Literature Monitoring Training

Practical training on literature search strategy, abstract screening, article assessment, case identification, inclusion/exclusion rationale, and documentation.

Signal Management Training

Training covering signal detection, validation, prioritization, assessment, case-series review, literature evaluation, tracking, and closure.

Aggregate Reporting Training

Training on PSUR, PBRER, DSUR, data lock points, safety-data compilation, literature, signals, exposure, and benefit-risk evaluation.

Risk Management Training

Training on safety concerns, identified and potential risks, missing information, pharmacovigilance planning, and risk-minimization measures.

Safety Database Training

System- and process-focused training covering workflows, user roles, data entry, review stages, reporting, audit trails, and controlled use of the safety database.

PSMF & SDEA/PVA Training

Training on PV-system documentation, partner responsibilities, safety-data exchange, agreement requirements, reconciliation, and governance.

PV Quality System Training

Training covering SOP compliance, deviations, CAPA, change control, reconciliation, training compliance, metrics, audit readiness, and inspection readiness.

Training Topics We Can Cover

Depending on the client’s needs, MGS can provide training on:

• Introduction to pharmacovigilance
• AE vs ADR
• SAE and seriousness criteria
• SUSAR concepts
• Case validity
• ICSR lifecycle
• MedDRA
• Causality assessment
• Expectedness and listedness
• Case narrative writing
• Follow-up management
• Special situations
• Pregnancy and breastfeeding exposure
• Medication errors
• Overdose
• Misuse and abuse
• Off-label use
• Literature monitoring
• Signal management
• Aggregate reporting
• Risk management
• Safety databases
• SDEA / PVA
• PSMF
• PV SOPs
• PV quality systems
• Data integrity
• Audit readiness
• Inspection readiness
• Regulatory updates

Training Formats

MGS can provide training through:

• Instructor-led sessions
• Virtual training
• On-site training
• SOP-specific training
• Refresher training
• Induction training
• Case-based workshops
• Role-based training
• Customized client programs
• Knowledge assessments
• Practical exercises

Our Training Approach

• Assess Training Needs

Identify participant roles, experience levels, processes, SOPs, and competency requirements.

• Customize Content

Develop training material relevant to the organization’s products, systems, responsibilities, and operating model.

• Explain the Concept

Present regulatory and technical concepts in clear and practical language.

• Apply Through Examples

Use case scenarios, workflows, exercises, and examples to connect theory with actual PV activities.

• Assess Understanding

Where required, use quizzes, case exercises, or knowledge assessments to evaluate understanding.

• Document & Reinforce

Support training records, attendance, assessments, refresher needs, and ongoing competency development.

Typical Deliverables

Depending on scope, MGS can provide:

• Training presentations
• Training modules
• SOP training material
• Case studies
• Practical exercises
• Knowledge assessments
• Question banks
• Training attendance records
• Training evaluation forms
• Training completion records
• Competency-assessment support
• Refresher-training plans
• Training matrix support

Why Choose MGS

Practical PV Perspective

Training content is linked to real pharmacovigilance workflows and responsibilities.

Role-Based Learning

Programs can be tailored for processors, reviewers, medical personnel, quality teams, database users, managers, and business partners.

Case-Based Understanding

Examples and scenarios help participants apply concepts to actual safety situations.

SOP & Process Integration

Training can be aligned with client SOPs, safety agreements, workflows, and system requirements.

Flexible Delivery

Programs can be customized by topic, participant level, duration, delivery mode, and organizational need.

Who We Support

MGS can provide PV Training for:

• Marketing Authorization Holders
• Pharmaceutical companies
• Biopharmaceutical organizations
• CROs
• Generic-drug companies
• Pharmacovigilance teams
• Quality teams
• Medical reviewers
• Regulatory personnel
• Business partners
• New PV professionals
• Cross-functional teams with safety-reporting responsibilities