What you'll learn
By the end of this course, you’ll understand the principles of drug safety monitoring, regulatory compliance, case management, and signal detection used by global pharmaceutical companies.
Core topics
- Introduction to Pharmacovigilance
- Drug Development & Clinical Trials Overview
- Adverse Event Reporting & Case Processing
- Signal Detection & Risk Management
- Global Regulatory Guidelines (ICH, WHO, EMA, FDA)
Hands-on
- Case entry and narrative writing
- Using safety databases (Argus / ARISg concepts)
- Preparation of regulatory reports (CIOMS, PSUR)
- Mock audits and compliance reporting
- Capstone: End-to-end safety case handling
Course syllabus
01
Introduction to Pharmacovigilance
Definition, importance & scope
+
Topics: What is PV, its evolution, global need for drug safety and post-marketing
surveillance.
02
Drug Development & Clinical Trials
Preclinical to post-marketing phases
+
Topics: Clinical research phases, role of PV in each stage, GCP principles.
03
Case Processing & Data Entry
Adverse Event reporting workflow
+
Topics: Source documents, case intake, coding (MedDRA), narrative writing,
follow-ups, quality checks.
04
Regulatory Frameworks
ICH, WHO, EMA, FDA, CDSCO
+
Topics: Global safety reporting systems and compliance requirements.
05
Signal Detection & Risk Management
Data analysis & pattern identification
+
Topics: Quantitative signal detection, risk assessment, and corrective actions.
06
Aggregate Reporting
PSUR, PBRER & expedited reports
+
Topics: Compilation of periodic safety reports and compliance with timelines.
07
Pharmacovigilance Databases
Argus, ARISg overview
+
Topics: Workflow understanding, case life cycle management, safety database tools.
08
Audits & Compliance
QA and inspections
+
Topics: Audit readiness, documentation, CAPA and PV system inspections.
Projects & Capstone
Work on case-based exercises and simulations aligned with real-world pharmacovigilance practices.
- Case narrative writing from sample AE reports
- Preparation of CIOMS forms
- Mock case entry using simulated database
- Signal detection mini-project
- Compliance report creation
- Capstone: End-to-end adverse event processing workflow
Instructor
SP
Dr. Sneha Patel
Drug Safety Associate — 10+ years experience
Office hours: Wed & Sat 6–8 PM
Frequently Asked Questions
Is this course suitable for beginners?
Yes, it starts from the fundamentals and gradually progresses to advanced topics.
Will I get a certificate?
Yes, you’ll receive a recognized certificate upon successful completion of all modules and
capstone.
Can I get placement assistance?
Yes, our career support team provides interview guidance and job referrals to PV companies.