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Argus Safety Validation - Gratisol Labs

Oracle Argus Safety Database Configuration & Validation Training

Oracle Argus Safety Database for Pharmacovigilance is a comprehensive pharmacovigilance platform which enables pharmaceutical manufacturers to make faster and better safety decisions, optimize global compliance and easily integrate risk management. Gratisol Labs provides an in-depth training to the learners to accelerate their knowledge and skill set required for Oracle Argus Configuration, Support & Maintenance & Job.

The Oracle Argus Safety database  training is intended for the individuals who seek to implement their knowledge, skills and expand their career in Pharmacovigilance domain with the help of Oracle Argus Safety Database technology. The dedicated mentors make sure the learners to cover all topics under Oracle Argus course curriculum which will be useful for their career growth. Gratisol Labs offers Oracle Argus Safety Database training to become a skilled Drug safety specialist.

Oracle Argus Safety Database Basic Certification course for Drug Safety Associates

This Argus Safety Database basic training teaches you how to implement and configure the products included in Argus Standard Edition (Argus Safety, Argus Interchange, Argus Affiliate, Argus Un-blinding), Argus Japan, as well as other new features introduced in Argus 8 in addition to Oracle B2B and BIP.

Topics we cover:

  • Apply the different application architecture strategies to real life scenarios
  • Develop the Skills to navigate and use the basic Argus application.
  • Perform business and system level configurations in Argus Console.
  • Manage expedited reporting by using configuration options in Argus Console, Interchange and AG Services.
  • Configure and transmit expedited reports to regulatory authorities using E2B R3 reports.
  • Identify the updates to MedWatch Reports in Argus Safety.
  • Configure and transmit eVAERS report to FDA CBER.
  • Execute Local Case Data Lock.
  • Implement Oracle B2B as EDI Gateway.
  • Implement Oracle BIP for Aggregate reporting.

Benefits to You

By completing this course, you’ll develop the knowledge and skills to effectively configure Argus modules. You’ll understand how to make the most out of your implementation.

This course teaches you how to configure the products included in Argus Standard Edition (Argus Safety, Argus Interchange, Argus Affiliate, Argus Un-blinding), Argus Japan, as well as other new features introduced in Argus 8 in addition to Oracle B2B and BIP.

Topics we cover:

  • Perform Configuration & Validation of the Oracle Argus Safety Database.
  • Develop the Skills to navigate and use the basic Argus application.
  • Perform business and system level configurations in Argus Console.
  • Manage expedited reporting by using configuration options in Argus Console, Interchange and AG Services.
  • Configure and transmit expedited reports to regulatory authorities using E2B R3 reports.
  • Identify the updates to MedWatch Reports in Argus Safety.
  • Configure and transmit eVAERS report to FDA CBER.
  • Execute Local Case Data Lock.
  • Implement Oracle B2B as EDI Gateway.
  • Implement Oracle BIP for Aggregate reporting.

Benefits to You

By completing this course, you’ll develop the knowledge and skills to effectively Configure & Validate Argus Safety.

Oracle Argus Safety Database Specialist Certification Overview – Advanced

The Oracle Argus Safety Database Implementation Specialist certification is designed for individuals who possess a strong foundation and expertise in selling and implementing the Oracle Argus Enterprise Edition.  This certification covers topics such as: Solution Product Overview and Positioning, Product Features and Functions, Architecture, Configuration and Integration.

Certification differentiates candidates in the marketplace by providing a competitive edge through proven expertise.  Up-to-date training and field experience are recommended.

Oracle Argus Safety Database certification is available to all candidates. This certification qualifies as competency criteria for the Oracle Argus Certification.

Argus Standard Validation  – Advanced Module

Course Description

Oracle Argus Safety Database course program will let the participants gain complete proficiency in pharmacovigilance platform.

The Oracle Argus Safety Database online course is ideally developed for pharmaceutical manufacturers who seek to build a lucrative career in the pharmaceutical safety domain.

In the Oracle Argus Safety Database online course, Gratisol Labs provides an in-depth training for the participants or learners to make them understand that the Argus technology offers web-based suite for pharmacovigilance which is used for case management and reporting. The Oracle Argus technology assures to offer a safety system which is used to manage data from varied sources and meet global compliance guidelines.

The Oracle Argus Safety Database technology is useful in accelerating drug safety by making use of the software solution that allows safety and risk management.

With the help of Oracle Argus Safety Database online course, the participants can:

  •      Gather, monitor and analyse safety data across clinical hearings, post market observation and patient care.
  •      Provides an entire integrated view of reported opposing events, clinical research and medical data.
  •      Recognizes risk in advance to simplify clinical developmental costs.

Target Audience

The Oracle Argus Safety Database course is intended for the below mentioned target audience, still if you are a newbie and want to make a career as Drug safety specialist in pharmacovigilance platform using Argus technology then the Oracle Argus course is the best option you can choose.

  •      Pharmaceutical professionals
  •      Drug safety Associates
  •      Drug safety managers
  •      Risk manager
  •      Professionals who want to build their career in pharmaceutical and clinical domain

ORACLE ARGUS SAFETY DATABASE COURSE CURRICULUM

Oracle Argus Safety Application Architecture

  • Argus Safety and Available Modules
  • Migration Methodology
  • Upgrade Methodology
  • Integration Overview

Argus Safety Business Configuration

  • Studies Configuration
  • Products and License Configuration

Argus Safety Case Processing

  • Safety Review
  • Data Entry
  • Medical Review
  • Quality Review

Argus Safety Expedited Reporting to Regulatory Authorities

  • Track Expedited Reports
  • Schedule, Generate and Transmit Expedited Reports
  • Accept Incoming E2B Reports

Argus Safety Business Configuration Continued

  • eVAERS
  • Medwatch Updates
  • ESM and AG Service Configuration
  • E2B R3
  • Expedited Reporting Rules

Advanced Conditions

  • Case Series
  • Create Advanced Condition Query Sets
  • Advanced Condition Library
  • Create Advanced Condition

Argus Safety System Configuration

  • Field Validations
  • Case Priority
  • Field Labels and User Defined Fields
  • Common Profile Switches
  • Codelist
  • System Numbering
  • Access Management
  • Workflow

E2B Extension Profile

  • Schedule E2B extended report
  • Argus Console Configuration
  • Configure ESM Mapping
  • Configure Database tables

Argus Local Affiliate Configuration

  • Create LAM Site
  • Create and Configure LAM Users
  • Perform Local Reports in Argus Affiliate
  • Create, Process and Route Cases to Argus Safety
  • Perform Local Labeling in Argus Affiliate
  • Access Argus Affiliate Module
  • Accept and Process LAM cases in Argus Safety

Argus Unblinding

  • Argus Unblinding module Configuration
  • Argus Console Configuration

Argus Safety Japan Configuration

  • Enable Argus Japan Module
  • Review Cases in Argus Japan Module
  • Create and Configure Japan Group and User
  • Access Argus Japan Module

Local Case Data Lock

  • Argus Console Changes
  • Perform Global and Local Lock with different scenarios
  • Local Prospective Reportable Case
  • Truly Local Case Configuration
  • Configure Global and Local User Privileges
  • Case Form Icon Changes

Argus Safety Multi-tenant

  • Enterprise Setup
  • Enterprise Configuration

Oracle B2B Gateway

  • B2B UI configuration
  • Argus Safety Configuration
  • Creation of Integration Tables in B2B Schema
  • Transmission and Tracking

Oracle BIP Integration

  • BI Publisher Overview
  • BIP Aggregate DSUR
  • BIP Aggregate Reporting
  • Architecture

JOB PROSPECTS

The Drug safety specialist draws an average salary of $90,000 USD per year in USA, Europe & India depending on the knowledge and hands-on experience in Oracle Argus Safety Database. The Drug Safety specialist job roles are in high demand and make a rewarding career.

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