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Oracle Argus Training

20 Hours
Online Instructor-led Training
USD 2800
Oracle Argus Training course and certification
18 Learners

About this Course
Oracle Argus online course refers to one of the market-leading solution for processing, analysing and reporting contrary event cases initiating in pre and post market drugs, vaccines, devices and other combination products. Oracle Argus online course intention is to make the learners to get used to a platform that allows the pharmaceutical manufacturers to improve safety, enhance global compliance and combine risk management.
Learn the concepts of Oracle Argus solution and its implementation.
Oracle Argus is a comprehensive pharmacovigilance platform which enables pharmaceutical manufacturers to make faster and better safety decisions, optimize global compliance and easily integrate risk management.
Uplatz provides an in-depth training to the learners to accelerate their knowledge and skill set required for Oracle Argus job.
Course Objective
The Oracle Argus training is intended for the individuals who seek to implement their knowledge, skills and expand their career with the help of Argus safety 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. Uplatz offers Oracle Argus training to become a skilled Drug safety specialist.
Course Description

Oracle Argus course program will let the participants gain complete proficiency in pharmacovigilance platform.
The Oracle Argus online course is ideally developed for pharmaceutical manufacturers who seek to build a lucrative career in the pharmaceutical safety domain. 
In the Oracle Argus online course, Uplatz 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 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 online course, the learners 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 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 managers
•       Risk manager
•       Professionals who want to build their career in pharmaceutical and clinical domain


Oracle Argus Training

Course Details & Curriculum

Argus Standard Edition Overview

·       Application Architecture

·       Argus Safety and Available Modules

·       Migration Methodology

·       Upgrade Methodology

·       Integration Overview

·       Live Installation

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


Career Path

The Drug safety specialist certification course with the help of expert professionals training is recognized across the globe. Because of the increased adoption of the Argus technology in various small and large pharmaceutical companies the participants are able to find the job opportunity easily. The leading companies hire Drug safety specialist to provide the most complete case data management and regulate reporting which gains productivity in the pharmaceutical firms. The Drug safety specialist can pursue a wide range of career paths.

The following are the job titles:

·       Drug Safety Associate

·       Medical Reviewer

·       Pharmacovigilance officer

·       Drug safety data manager

·       Pharmacovigilance scientist

·       Risk management specialist


Job Prospects

The Drug safety specialist draws an average salary of $87,531 per year depending on the knowledge and hands-on experience. The Drug Safety specialist job roles are in high demand and make a rewarding career.


Oracle Argus Interview Questions


1. Define Pharmacovigilance?

Pharmacovigilance is defined as science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the contrary effects of medications, biological products, herbalism and other medicine.

2. What are the Minimum Criterion Required For A Valid Case?

  • An identifiable reporter

  • An identifiable patient

  • A suspect product

  • An adverse drug event

3. Define Adverse Drug Event (ade)?

Any unfortunate medical occurrence in a patient or clinical investigation subject directed a pharmaceutical product and which does not essentially have a causal relationship with this treatment.

 4. Define Adverse Drug Reaction (adr)?

An adverse drug reaction is defined as a "response to a drug which is poisonous and unintended and which happens at doses normally used for prophylaxis, diagnosis  of disease."

5. What Is the Difference Between Ade And Adr?

There is not be a causal relationship between a drug and an ADE, whereas, there is a causal link between a drug and an adverse drug reaction.

6. Define volume 9a?

Volume 9A brings together general guidelines on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it combines international agreements reached within the International Conference on Harmonisation (ICH) framework.

Volume 9A is presented in four parts:

  • Part I - Guidelines for Marketing Authorisation Holders;

  • Part II - Guidelines for Competent Authorities and the Agency;

  • Part III - Guidelines for the electronic exchange of pharmacovigilance in the EU

  • Part IV - Guidelines on pharmacovigilance communication

 7. When should you Consider A Case To Be Medically Confirmed?

A case is considered to be medically confirmed if it contains at least a single event confirmed or reported by an HCP (Health Care Professional).

8. What is meant By Causality?

Causality is defined as a relationship between a set of factors. In Pharmacovigilance, causality means the relationship between the suspect product and the adverse drug event.

9. Mention Some Data Elements In Icsr?

Patient demographics: Age, gender and race.

Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and indication.

10. What Should A Narrative Comprise?

A narrative consist of precise and concise information about the source of report, patient demographics, patient’s medical history, suspect product details and adverse event details in an orderly manner.

11. Define Meddra?

Medical Dictionary for Regulatory Activities.

12. Mention The Hierarchy In Meddra?

  • System Organ Class (SOC)

  • High Level Group Term (HLGT)

  • High Level Term (HLT)

  • Preferred Term (PT)

  • Lower Level Term (LLT)


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