Oracle Argus Safety

Oracle Argus Safety + Console – Live Online

$999.00

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Description

Oracle Argus Safety Essentials + Console is a Live Online course that covers the basic and advanced concepts of managing drug safety data using the Oracle Argus Safety application. It also covers the process of using the Argus Console module of Argus Safety for system configuration, business configuration and administration of the Oracle Argus Safety software. It is intended for students and clinical research professional who are willing to make a career in Pharmacovigilance using the Oracle Argus platform. The course is also aligned for drug safety professionals looking to expand their skillset and explore opportunities as Argus Safety Consultants and Argus Safety Support specialists.

The course includes hands-on practical training on Oracle Argus Safety software used as a de-facto standard for managing drug safety data

The program is made up of 1 module, 8 topics and 9 Quizzes. It first covers the pre-requite topics on Pharmacovigilance and then takes you through the process of navigating the Oracle Argus Safety application. It then covers all the pharmacovigilance tasks performed in Oracle Argus Safety including Case entry, Case Triage, Medical coding, Medical review, Narrative writing, Quality control and Reporting.

As a part of Argus Console, the course covers all the activities related to the configuration of Users, System, Code-lists, Products and Licenses, Studies and Expedited Reporting rules.

On completing your enrolment for the Oracle Argus Safety Essentials + Console program you will instantly get access to our online learning portal and the Oracle Argus Safety software.

The Oracle Argus Safety – Live Online sessions will be scheduled with the Faculty.

Note: This program includes access to the Argus safety software without console level access. Console level access to the application can be purchased separately if desired.

Find more information about the Oracle Argus Safety application – What is Oracle Argus Safety

Key Features

 

  • Live Online Sessions with the Faculty via Web-conferencing
  • 24×7 access to the Oracle Argus Safety software
  • Training on actual Cases used in the industry
  • Course Instructor support via Email
  • Full access to e-Learning Portal containing Recorded Lectures.

Curriculum

Module 0 – Principles of Pharmacovigilance
  • General Overview of Pharmacovigilance
  • History and aim of Pharmacovigilance
  • Drug dependence
  • Vaccine Vigilance
  • Principles of Signal Detection in Pharmacovigilance
  • Communication in Pharmacovigilance
  • Post-Marketing Surveillance
Chapter 1 – Overview and Navigation
  • Process of Logging in
  • User Interface and Navigation
  • Functionality of User Interface Elements
Chapter 2 – Overview of Argus Menus
  • Business Process Workflow
  • Active Cases and Case actions
  • Worklist
  • Reports
  • Dashboard and Utilities
Chapter 3 – Case Form Features
  • Tabs and Fields of Case Form
  • Management of cases using Case Form fields
Chapter 4 – Drug and Event Coding
  • Coding Terms and MedDRA Browser
  • Drug and Event Coding using MedDRA and WHODD
Chapter 5 – Case Entry and Processing
  • Case Management Workflow
  • Case Processing – Spontaneous case
  • Case Processing – Sponsored Trial case
Chapter 6 – Advanced Conditions
  • Overview of Advanced Conditions
  • Building Complex Queries
Chapter 7 – Reporting and Submissions
  • Reporting Capabilities of Argus Safety
  • Periodic Safety Update Reports (PSUR)
  • Clinical Trial Periodic Reports (CTPR)
  • IND and NDA Reports
  • Case Data Analysis, Case Listing, CIOMS II Line Listing
Chapter 8 – Oracle Argus Safety Console
  • Argus Safety Configuration
  • User Configuration
  • Code List Configuration
  • Products and License Configuration
  • Studies Configuration
  • Expedited Report Rules Configuration
  • System Configuration
  • Accessing Tools
  • Data Privacy
Course Completion
  • Final Assessment
  • Course Certification

Certification

 

At the end of the course, students will be awarded a certificate of completion.

Duration

 

The duration of this program is 3 months.

Live Online Sessions shall be scheduled with the faculty once a week. You may select your preferred timings below:

  • Weekends at 11:00am EST OR
  • Weekdays at 8:00pm EST

If you would like to request a specific schedule please discuss with our team and we will try our best to accommodate it.

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