Professional Program in Pharmacovigilance
Build a Career in Drug Safety & Regulatory Compliance
Master Adverse Event Reporting, Case Processing, Drug Safety Monitoring & Global PV Regulations.
What is Pharmacovigilance (PV)?
Pharmacovigilance (PV) is the science and process of monitoring, assessing, and preventing adverse effects of pharmaceutical products.
It ensures:
- Drug Safety
- Patient Protection
- Regulatory Compliance
- Risk Management
- Pharmacovigilance professionals play a crucial role in safeguarding public health.
Why Learn Pharmacovigilance?
- High Demand in Pharma & Healthcare
Rapid Growth in Drug Safety Industry
Attractive Salary Packages
Stable & Long-Term Career
Pharmacovigilance professionals are needed in:
- Pharmaceutical Companies
- CROs (Contract Research Organizations)
- Biotech Firms
- Regulatory Authorities
- Clinical Research Organizations
Why Join Our Training Program?
Industry-Oriented Curriculum
Real-Time Case Processing Practice
Hands-On Safety Database Training
Global Regulatory Guidelines Training
Experienced Industry Trainers
Resume Building & Interview Preparation
Placement Assistance
Online & Offline Batches Available
Pharmacovigilance Course Modules
Module 1: Introduction to Pharmacovigilance
- Overview of PV
- Drug Development Process
- Roles & Responsibilities in PV
- Types of Adverse Drug Reactions (ADR)
Module 2: Case Processing & Reporting
ICSR (Individual Case Safety Report)
Case Intake & Triage
Data Entry & Medical Coding
Narrative Writing
Follow-up Procedures
Module 3: Global Regulatory Guidelines
ICH Guidelines
FDA Regulations
EMA Regulations
CDSCO Guidelines
GVP (Good Pharmacovigilance Practices)
Module 4: Safety Databases
Introduction to Safety Databases
Argus Basics (Overview)
Workflow & Case Management
Quality Check (QC) Process
Module 5: Signal Detection & Risk Management
- Signal Detection Process
- Risk Assessment
- Benefit-Risk Evaluation
- Periodic Safety Update Reports (PSUR)
Module 6: Real-Time Practical Training
- Case Processing Practice
- Medical Coding Exercises
- Mock Safety Reporting
- End-to-End Case Handling
What You Will Practice
- Real Adverse Event Case Scenarios
- Narrative Writing
- Regulatory-Compliant Documentation
- Database Workflow Practice
- Capstone Project in PV
Frequently Asked Questions (FAQ)
Pharmacovigilance is the process of monitoring drug safety and reporting adverse drug reactions.
Yes. It is one of the best career options for pharmacy and life science graduates.
No programming knowledge is required for Pharmacovigilance.
The course duration is 2–4 months depending on the batch.
Yes. The course includes hands-on case processing and safety reporting practice.
Freshers can expect ₹3.5–5 LPA depending on skills and company.
Yes. We provide resume support, mock interviews, and job guidance.