Overview:

This advanced course provides a comprehensive understanding of safety databases used in Pharmacovigilance. It focuses on technical aspects of case processing, including case entry, follow-up, duplicity checks, and database management. Learners will gain hands-on experience working with safety databases, ensuring data accuracy, compliance, and effective workflow management. This course emphasizes the critical role of safety databases in end-to-end ICSR management.

Objectives:

1. To understand the fundamentals of safety databases and their significance in Pharmacovigilance.
2. To develop proficiency in case entry, follow-up, and correction processes.
3. To master advanced database operations such as duplicity checks, worklist management, and reconciliation.
4. To handle special scenarios, compliance tracking, and audit readiness within safety databases.

Outcomes:

By the end of this course, learners will:

• Demonstrate expertise in processing ICSRs within safety databases.
• Ensure case accuracy, completeness, and compliance with global regulatory requirements.
• Develop technical skills to manage complex database operations, including reconciliation and audit preparation.
• Gain the ability to optimize workflows and resolve database-related challenges.