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PHARMACOVIGILANCE

PHARMACOVIGILANCE

Categories: BIO
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About Course

Focused on drug safety and regulatory compliance, this course prepares students for the pharmaceutical industry. It follows international standards for monitoring the effects of medicines. The first month covers the science of adverse drug reactions, while the second month focuses on actual case processing and reporting as per FDA/EMA standards.

What Will You Learn?

  • Drug Safety Monitoring & Reporting
  • Adverse Drug Reactions (ADR) Coding
  • MedDRA & WHO-DD Coding
  • Narrative Writing & Signal Detection
  • Regulatory Compliance (HIPAA/GCP)
  • Industry Tools: Argus Safety (Overview), MedDRA, Oracle PV
  • Hands-on Industry Projects

Course Content

Month 1: Theory & Concepts (Monday – Friday Classes)

Module 1: Introduction to Pharmacovigilance

Module 2: ADR Case Processing

Module 3: Medical Coding

Module 4: Narrative Writing

Module 5: Regulatory Reporting

Module 6: Signal Detection

Month 2: Industry-Level Projects

Project 1: Individual Case Safety Report (ICSR)

Project 2: Safety Signal Analysis

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Your Instructor

v93117148@gmail.com