ARGUS TOOL WORKFLOW

ARGW: Argus Tool Workflow

At Qtech-Sol, we specialize in training clinical research and drug safety professionals to work with industry-leading tools and systems. The Argus Tool Workflow (ARGW) program is designed for individuals who want to master Oracle Argus Safety, the most widely used pharmacovigilance (PV) database system in the pharmaceutical industry.
This program provides a hands-on, role-based learning experience, equipping learners with the essential knowledge and skills required to manage safety data effectively and ensure compliance with global pharmacovigilance regulations
As a trained Argus Safety professional, you will play a critical role in handling case processing, database navigation, regulatory reporting, and signal management — essential functions in today’s drug safety environment

.

SIP – Self-Paced Online with Support

1. Course Duration: 3 weeks (80 hours)
2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).

Learners enrolling in the Argus Tool Workflow (ARGW) program should have a basic understanding of drug safety principles and computer skills. Familiarity with the clinical research process (Phases I–IV), adverse events (AEs/SAEs), and pharmacovigilance concepts is expected. Awareness of regulatory guidelines such as FDA, EMA, ICH-GCP, HIPAA, and 21 CFR Part 11 is helpful. Comfort with Microsoft Office, database navigation, and accurate data entry or coding is required, with exposure to MedDRA/WHO-DD being an advantage. Prior experience with PV tools like ArisG or MedDRA is beneficial but not mandatory. Key attributes include strong attention to detail, analytical thinking, and effective written communication for narrative writing.

   Key Functions You Will Learn:

Participants in the Argus Tool Workflow program will gain expertise in:

1. Case Intake & Triage: Recording adverse event data, importing cases, and performing initial triage.
3. Case Processing: Entering data in Argus Safety, coding with MedDRA and WHO-DD, and updating case details.
5. Workflow Navigation: Understanding Argus case workflow stages — intake, data entry, medical review, quality check, and reporting.
7. Regulatory Reporting: Generating CIOMS, MedWatch, and E2B submissions to health authorities (FDA, EMA, Health Canada).
9. Narrative Writing in Argus: Creating concise narratives directly in the system.
11. Duplicate Management: Identifying, linking, and managing duplicate cases.
13. Quality Control: Performing data checks and applying validation rules.
15. Signal Detection Support: Using Argus features to identify safety signals and support periodic reporting (PSURs, DSURs).
17. Audit Readiness: Maintaining compliance for Argus system audits and inspections.

1. Member Registration: Sign up as a member on our LMS portal.
2. Course Selection: Choose ARGW – Argus Tool Workflow.
3. Enrollment & Tuition: Complete the online enrollment and payment process.
4. Access Learning Materials: Start learning via narrated presentations, reading modules, practice quizzes, and Argus simulation exercises.
5. Support: Get guidance from SMEs through email and Google Meet sessions.
6. Assignments & Tests: Submit tasks and assessments online.
7. Final Exam: Complete your final exam to validate your learning.
8. Certificate: Receive your certificate and transcript upon successful completion.
9. Post-Training Support: Access resume-building, mock interviews, and RMS (Resume Marketing Services).

To succeed in pharmacovigilance roles involving Argus Safety, candidates should have a foundation in drug safety principles, case processing, and regulatory compliance.

Our program offers hands-on Argus practice files and case simulations, ensuring that students gain real-world exposure to PV workflows.

   Eligible backgrounds include:

1. Pharmacy
2. Life Sciences
3. Nursing
4. Medicine / MBBS
5. Biomedical Sciences

1. Entry Level: Bachelor’s degree in science, pharmacy, or related field.
2. Preferred: Master’s degree or prior drug safety / clinical research experience

1. Gain hands-on Argus Safety experience through real-world case scenarios.
2. Master MedDRA coding, SAE handling, and regulatory reporting in Argus.
3. Improve your resume and employability for PV and drug safety roles.
4. Flexible self-paced learning with SME guidance.
5. Prepare for roles like Drug Safety Associate, Argus Case Processor, PV Specialist, or Medical Reviewer Assistant.

1. ISoP (International Society of Pharmacovigilance)
2. DIA (Drug Information Association)
3. RAPS (Regulatory Affairs Professionals Society)
4. Pharmaceutical Journals: Drug Safety, Journal of Pharmacovigilance
5. Regulatory Resources: FDA, EMA, Health Canada websites

1. Drug Safety Associate (DSA)
2. Pharmacovigilance Case Processor
3. Safety Database Specialist (Argus)
4. Regulatory Case Submission Specialist
5. Adverse Event 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.