Pharmacovigilance Course | Drug Safety & Reporting | PV Training

Pharmacovigilance Course: Drug Safety & Reporting

Course enrollment

$120.00

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This course includes

Lessons
50
Duration
30h, 20m
Skill Level
Advance
Language
English, French
Certificate
After completed
Deadline
Nov 23, 2026

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Overview
Curriculum
Requirements

Module Name - Pharmacovigilance

Course Overview

This course provides an in-depth understanding of Pharmacovigilance (PV) and Materiovigilance (MV)—from foundational principles and regulatory structures to real-world tools like eCRFs, safety trackers, MedDRA coding, and AI-based PV automation. Structured with hands-on, video-based learning, learners will gain the skills needed for regulatory compliance, safety signal reporting, adverse event documentation, and global surveillance standards.

What You Will Learn

Evolution, scope, and reporting mechanisms

Understanding PV and MV fundamentals, evolution, and reporting mechanisms.
Clinical safety workflows

eCRFs, narrative writing, and SAE documentation practices.
Trigger lists in pharmacovigilance

Including landmark trials and safety signal detection.
Reporting systems

SUGAM, AWS, and trackers for dossier & source docs.
Expectedness assessment & SMP development

Line listing techniques and safety management plans.
Artificial intelligence in pharmacovigilance

AI-based PV automation and machine learning applications.
Global regulatory bodies

Reporting requirements and compliance standards.
MedDRA structure and coding

MedDRA browser walkthrough and practical coding exercises.

Why Choose This Course?

Comprehensive coverage of both Pharmacovigilance and Materiovigilance principles.
Hands-on, video-based learning with real-world tools and systems.
Practical exposure to eCRFs, safety trackers, and MedDRA coding.
AI-based PV automation and modern technology integration.
Aligned with global regulatory standards and compliance requirements.
Supportive for transition into pharmacovigilance and drug safety roles.

Career Outcomes

After completion, learners can pursue roles such as:

Pharmacovigilance Associate
Drug Safety Specialist
Safety Data Management Professional
PV Operations Coordinator
MedDRA Coding Specialist

Course Curriculum

Through comprehensive modules and practical exercises, you'll master pharmacovigilance fundamentals, drug safety monitoring, adverse event reporting, and regulatory compliance. The curriculum covers everything from basic PV principles to advanced AI-based automation tools, ensuring you develop both theoretical knowledge and practical skills for professional pharmacovigilance careers.

Foundation & Fundamentals

6 Lessons
10h, 30min

Beginner

This module provides the essential foundation for pharmacovigilance, covering basic terminology, introduction to the field, and fundamental concepts that every PV professional needs to know.

Introduction to Pharmacovigilance

Preview
Evolution and Scope of PV
Basic PV Terminology
Materiovigilance (MV) Basics
Regulatory Framework Overview
Global PV Guidelines

Safety Monitoring & Reporting

8 Lessons
12h, 45min

Intermediate

This module focuses on safety monitoring systems, adverse event documentation, and reporting mechanisms essential for pharmacovigilance operations.

Adverse Event Documentation

Preview
Serious Adverse Event (SAE) Reporting
eCRF Design for Safety Data
Safety Signal Detection
Trigger Lists in PV
Expectedness Assessment
SMP Development
Line Listing Techniques

PV Systems & Tools

5 Lessons
8h, 15min

Intermediate

This module covers essential PV systems, databases, and tools needed for efficient safety monitoring and reporting.

SUGAM Portal Walkthrough

Preview
AWS for PV Operations
Safety Trackers & Dossiers
Source Document Management
PV Database Management

MedDRA & Coding

4 Lessons
6h, 20min

Intermediate

This module teaches MedDRA structure, coding principles, and browser navigation for standardized adverse event terminology.

MedDRA Structure Overview

Preview
MedDRA Coding Principles
MedDRA Browser Navigation
Practical Coding Exercises

Regulatory Compliance

5 Lessons
7h, 30min

Advanced

This module covers regulatory requirements, compliance standards, and reporting timelines for different global markets.

FDA PV Requirements

Preview
EMA & EU Regulations
CDSCO & Indian Regulations
Reporting Timelines & Deadlines
Audit & Inspection Readiness

AI & Advanced PV

3 Lessons
5h, 15min

Advanced

This module introduces modern AI tools and advanced automation techniques for pharmacovigilance operations.

AI in Pharmacovigilance

Preview
Machine Learning for Signal Detection
PV Automation Tools

Requirements

To get the most out of this Pharmacovigilance course, please ensure you meet the following requirements. These prerequisites will help you successfully complete the program and apply your learning effectively.

No Prior Writing Experience

This course is beginner-friendly and does not assume prior medical writing knowledge. No prior regulatory writing experience is needed to begin.
Life Sciences Background

Suitable for graduates in life sciences, pharmacy, nursing, or related fields. A basic understanding of clinical trials will be helpful but not mandatory.
Computer with Internet Access

You'll need a computer with internet connection for research and online resources. Access to Microsoft Word software is also required for document creation and formatting exercises.