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Pharmacovigilance
Learn adverse event reporting, drug safety monitoring, and pharmacovigilance regulations in the pharmaceutical industry.
What You'll Learn
- Introduction to Pharmacovigilance
- Case Report Analysis
- ICSR Processing
- Clinical Trial Safety Monitoring
- Portfolio polish
Curriculum
5 modules · 20 topics covered
1
Module 1: Foundation
- Introduction to Pharmacovigilance
- Drug Safety Fundamentals
- Adverse Drug Reaction (ADR) Concepts
- Regulatory Framework Overview
2
Module 2: Advanced Projects
- Case Report Analysis
- Signal Detection Study
- Risk Management Plan Project
- Causality Assessment Case Study
3
Module 3: Tools & Skills
- ICSR Processing
- MedDRA Coding
- Pharmacovigilance Databases (VigiBase/Argus)
- Aggregate Safety Reporting
4
Module 4: Industry Applications
- Clinical Trial Safety Monitoring
- Post-Marketing Surveillance
- Regulatory Submissions (PSUR/PBRER)
- Pharma Industry Compliance
5
Module 5: Career & Portfolio
- Portfolio polish
- LinkedIn & branding
- ATS-ready resume
- Mock interviews & feedback
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Quick Facts
- Department
- Bio & Life Sciences
- Modules
- 5
- Topics
- 20
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