GVP Module I · IPC PV Guidance V2.0 · DMS-Integrated

Your Team, Trained and Audit-Ready

Role-specific pharmacovigilance training programmes and complete SOP libraries for MAH teams — delivered by our experienced drug safety professionals.

Get a Free PV Consultation Call +91-7428116100

Why Training Matters

Why is PV Training a Regulatory Requirement?

GVP Module I (Pharmacovigilance Systems and their Quality Systems) requires MAHs to ensure that all personnel involved in pharmacovigilance activities are appropriately qualified and trained. The IPC PV Guidance V2.0 mandates that training records be maintained and documented in the PvMF. CDSCO inspectors routinely verify the existence of training programmes during PV system inspections.

Training Programmes

Training Programmes We Deliver

Role-specific programmes for every level of your organisation

All Staff

PV Awareness Training

A mandatory foundation-level programme covering the basics of pharmacovigilance: what an adverse event is, why reporting matters, how to identify and report AEs, and the regulatory consequences of non-reporting. Suitable for medical representatives, sales teams, QA and regulatory personnel.

Safety Team

PV Operations Training

In-depth training for the designated PV team covering ICSR triage, MedDRA coding, causality assessment, E2B(R3) reporting formats, and use of the Auriga Safety System database.

Leadership

PVOIC / Manager Training

Focused training for the Pharmacovigilance Officer in Charge covering PvMF preparation, signal management, aggregate report oversight, audit preparation, and regulatory interface management.

Onboarding

SOP Implementation Training

Role-specific walk-through of all approved SOPs with assessment and competency sign-off. Delivered at onboarding and upon major SOP revisions.

Annual

Annual Refresher Training

Yearly refresher covering regulatory updates (new CDSCO circulars, ICH guidelines, MedDRA version updates), lessons learned from internal audits, and emerging safety topics. Ensures all personnel remain current and inspection-ready.

SOP Development

Complete SOP Library for Your PV System

Auriga develops, reviews, and versions all Standard Operating Procedures required for your PV system — covering every activity from adverse event receipt to regulatory submission. All SOPs are stored in our Document Management System (DMS) with full version control, approval workflows, and read/acknowledgement tracking for compliance evidence.

✓ AE/SAE Receipt and Triage
✓ ICSR Data Entry and Quality Review
✓ MedDRA Coding Procedure
✓ Causality Assessment
✓ E2B(R3) Submission and Reconciliation
✓ Duplicate Case Management
✓ Literature Monitoring and Reconciliation
✓ Signal Detection and Management
✓ Aggregate Report Preparation
✓ PvMF Preparation and Maintenance
✓ Safety Data Exchange Agreement Management
✓ PV Audit and CAPA Management
✓ Training Management
✓ Business Continuity for PV Operations

Get Your Team Audit-Ready Today

Contact us to discuss a customised training and SOP package for your organisation.

+91-7428116100 Schedule a Free Consultation

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