CASE INTAKE & CASE PROCESSING WORKFLOW

Case Intake & Case Processing Workflow

In pharmacovigilance (PV), case intake and case processing are the backbone of safety operations. Every reported adverse event (AE) or serious adverse event (SAE) must be captured, validated, processed, coded, and reported in compliance with regulatory standards. A systematic and efficient workflow ensures timely submissions, high-quality data, and patient safety.

The CASE: Case Intake & Case Processing Workflow program introduces learners to the end-to-end safety case lifecycle, from initial receipt to database entry, coding, quality checks, and regulatory reporting. This training is essential for aspiring Drug Safety Associates, Pharmacovigilance Case Processors, and Clinical Safety Professionals.

SIP – Self-Paced Online with Support

1. Course Duration: 3 weeks (80 hours)
2. Format: Self-Paced Online with Support (presentations, readings, practice quizzes, and simulated case processing exercises).

   By completing this program, learners will be able to:

1. Understand the workflow of AE/SAE case intake, triage, and validation.
2. Differentiate between valid vs. invalid cases and apply minimum criteria checks.
3. Perform data entry into safety databases (e.g., Argus Safety, ArisG).
4. Apply MedDRA and WHO-DD coding for consistency in case processing.
5. Conduct quality checks (QC) to ensure data accuracy and completeness.
6. Understand regulatory reporting timelines for ICSRs and expedited reports.
7. Learn about duplicate management and follow-up processes.
8. Practice narrative writing for AE/SAE case descriptions.

This program is ideal for:

1. Drug Safety / PV Associates working in case processing roles
2. Clinical Research Coordinators / Assistants handling AE reporting
3. Healthcare professionals transitioning into PV roles
4. Career changers entering drug safety and pharmacovigilance

1. Gain practical knowledge of the case intake and processing workflow.
2. Develop job-ready skills in safety data entry, coding, and reporting.
3. Build confidence in narrative writing and quality control.
4. Be prepared for regulatory audits and inspections.
5. Pathway to advanced PV programs (ICSR, ARGW, SDRM, PVIR).

1. Drug Safety Associate (DSA)
2. Case Processing Specialist
3. ICSR Case Processor
4. Pharmacovigilance Coordinator
5. Clinical Safety Data Analyst

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.