Introduction to Pharmacovigilance Overview of drug safety and pharmacovigilance Roles and responsibilities in PV

Adverse Events & Case Processing Types of adverse events Individual Case Safety Reports (ICSRs)

Global Regulatory Guidelines FDA, EMA, and ICH regulations Pharmacovigilance System Master File (PSMF)

Safety Databases Safety data collection and case lifecycle Data entry and workflow management

Signal Detection & Risk Management Signal identification methods Risk Management Plans (RMP)

Aggregate Reporting PSUR, PBRER, and DSUR reports Benefit-risk evaluation concepts

Quality & Compliance Audits, inspections, and documentation Data quality standards

Real-Time Case Studies Practical drug safety scenarios Industry-based examples

Career & Interview Preparation Resume and interview guidance Job roles and career pathways

Pharmacovigilance Training

Pharmacovigilance Training – Course Overview

Pharmacovigilance focuses on monitoring, assessing, and preventing adverse drug reactions to ensure patient safety and regulatory compliance.
This training equips you with practical skills to work on real-world safety data, global regulations, and industry-standard tools used by pharma companies.

Start Your Learning Journey with Vyava Technologies

Join Free Demo Class Enquire Now

Why Learn Pharmacovigilance?

With increasing drug safety regulations worldwide, pharmacovigilance professionals are in high demand.
This course opens stable career paths in pharma, clinical research, and regulatory compliance.

Drug Safety & Patient Protection

Monitor adverse drug reactions and ensure patient safety throughout the drug lifecycle.

Global Regulatory Compliance

Work with international safety regulations like ICH, FDA, EMA, and WHO guidelines.

Case Processing & Reporting

Learn end-to-end adverse event case processing and regulatory submissions.

Signal Detection & Risk Management

Identify safety signals and support benefit–risk assessments.

Cross-Industry Applications

Opportunities across pharma companies, CROs, hospitals, and regulatory agencies.

High-Demand Career Opportunities

Build a stable career as a Drug Safety Associate, PV Analyst, or Safety Scientist.

Key Features of Pharmacovigilance Training

What You Will Learn in Pharmacovigilance Training

This curriculum covers core pharmacovigilance concepts, real-time case processing, regulatory reporting, and safety database operations.

Introduction to Pharmacovigilance

Overview of drug safety and pharmacovigilance
Roles and responsibilities in PV

Adverse Events & Case Processing

Types of adverse events
Individual Case Safety Reports (ICSRs)

Global Regulatory Guidelines

FDA, EMA, and ICH regulations
Pharmacovigilance System Master File (PSMF)

Safety Databases

Safety data collection and case lifecycle
Data entry and workflow management

Signal Detection & Risk Management

Signal identification methods
Risk Management Plans (RMP)

Aggregate Reporting

PSUR, PBRER, and DSUR reports
Benefit-risk evaluation concepts

Quality & Compliance

Audits, inspections, and documentation
Data quality standards

Real-Time Case Studies

Practical drug safety scenarios
Industry-based examples

Career & Interview Preparation

Resume and interview guidance
Job roles and career pathways

Career Opportunities After Pharmacovigilance Training

Salary Packages

Pharmacovigilance offers stable and growing career opportunities within the pharmaceutical and clinical research sectors.

Role	Salary Range
Drug Safety Associate	₹3.5 LPA – ₹6 LPA
Pharmacovigilance Executive	₹4 LPA – ₹7 LPA
PV Case Processing Associate	₹4.5 LPA – ₹8 LPA
Safety Data Analyst	₹6 LPA – ₹10 LPA
Pharmacovigilance Scientist	₹8 LPA – ₹15 LPA
Regulatory & Safety Compliance Specialist	₹10 LPA – ₹18 LPA