Course Overview

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary objective of Pharmacovigilance is to ensure patient safety and monitor the benefit-risk profile of medicinal products throughout their lifecycle.

Course Modules

Module 1: Introduction to Pharmacovigilance

Definition and History of Pharmacovigilance
Importance of Drug Safety
Pharmacovigilance Objectives
Scope of Pharmacovigilance
Drug Development Process
Clinical Trials Overview
Post-Marketing Surveillance
Healthcare Ecosystem and Stakeholders

Module 2: Drug Safety Basics

Adverse Event (AE)
Adverse Drug Reaction (ADR)
Serious Adverse Event (SAE)
Serious Adverse Drug Reaction
Unexpected Adverse Event
Severity vs Seriousness
Side Effects
Toxicity
Medication Errors
Product Quality Complaints
Lack of Efficacy
Off-Label Use
Overdose
Misuse and Abuse

Module 3: Pharmacovigilance Regulations

ICH Guidelines Overview
ICH E2A
ICH E2B(R3)
ICH E2D
ICH E2F
Good Pharmacovigilance Practices (GVP)
FDA Regulations
EMA Regulations
MHRA Overview
CDSCO Regulations (India)
WHO Pharmacovigilance Programme

Module 4: Individual Case Safety Report (ICSR)

Introduction to ICSR
Four Minimum Criteria
Valid Case Identification
Sources of Cases
Case Receipt Process
Case Processing Workflow
Follow-Up Information
Duplicate Case Detection
Case Lifecycle

Module 5: Case Processing

Case Intake
Triage Process
Data Entry
Medical Review
Quality Review
Submission Process
Follow-Up Activities
Case Closure Process
Compliance Timelines

Module 6: Medical Coding

Introduction to MedDRA
MedDRA Hierarchy
SOC
HLGT
HLT
PT
LLT
Event Coding
Product Coding
WHO Drug Dictionary
Drug Coding
Trade Name Coding
Generic Name Coding

Module 7: Causality Assessment

WHO-UMC Scale
Naranjo Scale
Certain
Probable
Possible
Unlikely
Unassessable Cases
Signal Identification Basics

Module 8: Aggregate Reporting

Periodic Safety Update Report (PSUR)
Periodic Benefit-Risk Evaluation Report (PBRER)
Development Safety Update Report (DSUR)
Annual Safety Reports
Safety Data Analysis

Module 9: Signal Management

Signal Detection
Signal Validation
Signal Prioritization
Signal Assessment
Signal Communication
Benefit-Risk Evaluation
Risk Minimization Measures

Module 10: Risk Management

Risk Management Plan (RMP)
Risk Identification
Risk Evaluation
Risk Mitigation
Risk Communication
Safety Monitoring Activities

Module 11: Pharmacovigilance Databases

Argus Safety Overview
ARISg Overview
Veeva Vault Safety
Safety Database Workflow
Electronic Reporting Systems

Module 12: Literature Surveillance

Literature Search Process
Scientific Publications Review
Case Identification from Literature
Literature Screening
Literature Case Processing

Module 13: Quality and Compliance

Quality Management System (QMS)
Standard Operating Procedures (SOPs)
CAPA
Audits and Inspections
Regulatory Compliance
Documentation Practices

Module 14: Pharmacovigilance Career Development

Pharmacovigilance Departments
Entry-Level Roles
Drug Safety Associate (DSA)
Pharmacovigilance Associate
Case Processor
Medical Reviewer
Signal Detection Specialist
Aggregate Reporting Specialist
Safety Scientist
Career Progression Path

Practical Training

✅ Real-Time Case Processing Demonstration

✅ MedDRA Coding Exercises

✅ Narrative Writing

✅ Seriousness Assessment

✅ Expectedness Assessment

✅ Causality Assessment

✅ Follow-Up Handling

✅ Quality Check Activities

✅ Safety Database Demonstration

✅ Mock Case Studies

Interview Preparation

🎯 Pharmacovigilance Interview Questions

🎯 HR Interview Preparation

🎯 Resume Building Guidance

🎯 LinkedIn Profile Optimization

🎯 Professional Communication Skills

🎯 Corporate Etiquette Basics

What You'll Achieve

Upon completion of this program, learners will gain a comprehensive understanding of Pharmacovigilance processes, drug safety regulations, case processing workflows, medical coding, aggregate reporting, signal management, risk management, and industry best practices used within global pharmaceutical organizations.