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Pharmacovigilance Certification Course: Drug Safety (2026)
Published 6/2026
Created by Primepharmacovigilance academy
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Level: All Levels | Genre: eLearning | Language: English | Duration: 30 Lectures ( 8h 42m ) | Size: 11.1 GB

Pharmacovigilance, Drug safety, Drug development, ICSR, Adverse events, MedDRA, PSUR, RMP, DSUR, Signal detection,
What you'll learn
Strong understanding of Pharmacovigilance principles
Practical knowledge of ICSR processing
Understanding of global regulatory requirements (ICH, EMA, FDA, WHO & GVP)
Hands-on knowledge of MedDRA coding and safety reporting
Risk management and signal detection concepts
Clinical trial safety reporting requirements
Aggregate safety report preparation (PBRER, PSUR)
Real-world pharmacovigilance case studies and examples
Interview preparation with commonly asked Pharmacovigilance questions
Career guidance for entry-level and experienced Pharmacovigilance professionals
Pharmacovigilance Fundamentals
Global Pharmacovigilance Regulations
Adverse Events (AE) and Adverse Drug Reactions (ADR)
Drug Safety Data Processing
Pharmacovigilance in Clinical Research
Requirements
No prerequisite is needed for this course.
Description
"This course contains the use of artificial intelligence"
Pharmacovigilance Career Masterclass: Drug Safety, Case Processing, Medical Coding & Interview Preparation
Course Overview
This course provides a comprehensive introduction to Pharmacovigilance and Drug Safety, covering the key concepts, processes, and industry practices used in pharmaceutical companies and contract research organizations (CROs).
Learners will gain an understanding of adverse event reporting, Individual Case Safety Report (ICSR) processing, medical coding, causality assessment, narrative writing, regulatory reporting requirements, and pharmacovigilance workflows. The course also includes interview preparation topics commonly discussed for entry-level pharmacovigilance and drug safety roles.
The content is designed for students, graduates, healthcare professionals, and individuals seeking foundational knowledge of pharmacovigilance and drug safety operations.
What You'll Learn
Fundamentals of Pharmacovigilance and Drug Safety
Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Pharmacovigilance Process and Workflow
Individual Case Safety Report (ICSR) Processing
Case Intake and Case Validation
Medical Coding Using MedDRA and WHO Drug Dictionary
Seriousness, Expectedness, and Listedness Assessment
Causality Assessment Methods
Narrative Writing and Case Documentation
Follow-Up Activities and Data Quality Review
Regulatory Reporting Requirements
Signal Detection and Risk Management Concepts
Aggregate Safety Reporting Fundamentals
Common Pharmacovigilance Interview Questions and Answers
Career Pathways in Drug Safety and Pharmacovigilance
Who this course is for
Students and professionals seeking career opportunities in Pharmacovigilance and Drug Safety
Pharmacy graduates interested in building a career in Pharmacovigilance, Clinical Research, and Regulatory Affairs
Professionals looking to enhance their knowledge of ICSR processing, case assessment, and drug safety reporting
Pharmacy, Life Sciences, Biotechnology, Chemistry, Nursing, Medical, and Allied Healthcare graduates
Pharmacovigilance professionals who want to strengthen their understanding of global regulations, GVP guidelines, and safety reporting requirements
Clinical Research Associates (CRAs), Clinical Data Management professionals, and Regulatory Affairs professionals seeking cross-functional knowledge
Homepage


https://www.udemy.com/course/pharmacovi ... afety-2026


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