Diploma in Pharmacovigilance & Data Management

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

Curriculum

• 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

Certification

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

Duration:   6 months