The Building Blocks of Your New Career

As a Drug Safety Associate, your ability to effectively manage Individual Case Safety Reports (ICSRs) is critical to ensuring patient safety and regulatory compliance. This course focuses on the essential processes of intake, triage, and follow-up, equipping you with the skills needed to validate cases, assess seriousness and expectedness, and execute timely follow-ups. These are the core responsibilities of a competent Pharmacovigilance professional.

Introduction

Every ICSR begins with the intake process, where the initial information is collected, validated, and entered into the safety database. From there, the triage process determines the case's priority based on seriousness and expectedness, ensuring timely action. Follow-up processes ensure that additional critical details are gathered to complete the case. This course provides a comprehensive understanding of these steps, helping you manage ICSRs efficiently and accurately.

Objectives

1. To understand the intake process, including handling safety mailboxes and validating case data.
2. To analyze triage processes, focusing on the assessment of seriousness and expectedness.
3. To develop skills for executing follow-up actions and meeting reporting timelines.

Outcomes

By the end of this course, learners will:

• Be proficient in managing the intake of ICSRs and ensuring case validity.
• Understand how to assess seriousness and expectedness during the triage process.
• Ensure timely follow-ups to gather missing information and adhere to reporting requirements.
• Develop the ability to manage end-to-end ICSR processes with efficiency and accuracy.

Skills You Will Gain

• Mailbox Management: Proficiency in organizing and managing safety mailboxes for timely processing.
• Case Validation: Expertise in identifying valid ICSRs and handling incomplete reports.
• Triage Decision-Making: Ability to assess seriousness and expectedness to prioritize cases effectively.
• Regulatory Timeliness: Knowledge of reporting timelines and adherence to compliance standards
• Follow-Up Execution: Skills in gathering and documenting additional case information to ensure completeness.