CATEGORY: Advanced Programs
Diploma in Pharmacovigilance & Data Management
Course Access: 180 days access
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.
- 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