Diploma in Pharmacovigilance & Data Management
CATEGORY: Advanced Programs

Diploma in Pharmacovigilance & Data Management

Course Access: 180 days access
Course Overview

Course Summary

The Advanced Diploma in Pharmacovigilance & Data Management (ADPV-DM) is designed to provide students a complete understanding of Pharmacovigilance and Clinical Data management processes, regulations and documentation. It equips you to start a career in Drug Safety or as a Clinical Data Management professional. The course is aligned to the requirements of the industry and  includes hands-on training modules on Oracle Argus Safety for Pharmacovigilance and Oracle Clinical  for Clinical Data Management.

Key Features

  • 24×7 access to the Oracle Argus Safety & Oracle Clinical software.
  • Full access to e-Learning Portal containing Multimedia Tutorials and Quizzes.
  • Course Instructor support via Discussion Forums


  • Module 1 – General Introduction
  • Module 2 – Epidemiology and Evidence Based Medicine
  • Module 3 – Pharmaceutical Medicine
  • Module 4 – Principles of Pharmacovigilance
  • Module 5 – Pharmacovigilance and Selected System Organ Classes
  • Module 6 – Pharmacovigilance Systems
  • Module 7 – Global Pharmacovigilance and Safety Standards
  • Module 8 – Pharmacovigilance Regulations and Guidelines
  • Module 9 – Pharmacoepidemiology
  • Module 10 – Oracle Argus Safety Essentials
  • Module 11 – Basics of Clinical Data Management
  • Module 12 – Clinical Data Management Processes and Standards
  • Module 13 – Clinical Data Management Systems
  • Module 14 – Oracle Clinical Fundamentals
  • Course Completion


At the end of the course, students will be awarded a certificate of completion.

Duration:   6 months

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