Buy the GCP R3 course & get a FREE eBook— your complete ICH-GCP R3 reference guide. Book Now →

  • AI ClinicalAI ClinicalNewRight Arrow
  • Clinical PracticeClinical PracticeRight Arrow
  • PharmacovigilancePharmacovigilanceRight Arrow
  • ManufacturingManufacturingRight Arrow
  • Laboratory PracticeLaboratory PracticeRight Arrow
  • DistributionDistributionRight Arrow
  • Medical DevicesMedical DevicesRight Arrow
  • Regulatory AffairsRegulatory AffairsRight Arrow
  • Research ComplianceResearch ComplianceRight Arrow
  • Health & SafetyHealth & SafetyRight Arrow
  • Quality AssuranceQuality AssuranceRight Arrow
  • BiostatisticsBiostatisticsTrendingRight Arrow
  • Pharmaceutical MedicinePharmaceutical MedicineNewRight Arrow
  • All Bundles
  • Clinical Trials Development
  • GCP & GxP Standards
  • GMP & Quality Assurance
  • Pharmacovigilance
  • Role Based
  • Distribution
  • Medical Devices
  • Medical Writing
  • AI Clinical
  • Quality Assurance
  • Biostatistics
  • Pharmaceutical Medicine
  • Customize your bundleBuild your own path
View all 30 learning paths
  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations Learning Path - courses at £199

About

Oracle Argus Safety provides a configurable platform for managing pharmacovigilance case processing, safety workflows, regulatory reporting, and safety data. Effective administration of the system requires a strong understanding of its console, configuration framework, security controls, workflows, and system maintenance requirements to support reliable and compliant pharmacovigilance operations.
This PV Systems – Advanced Oracle Argus Safety – Console, Configuration and Administration Training Course & Certification provides comprehensive knowledge of the Oracle Argus Safety Console, system configuration, user and role administration, workflow settings, product and event configuration, business rules, reporting configuration, system monitoring, configuration change control, security, audit trails, data integrity, validation considerations, troubleshooting, and system maintenance. Upon successful completion, learners receive a certification demonstrating their understanding of advanced Oracle Argus Safety configuration and administration practices.

Who Should Enrol?

  • Oracle Argus Safety Administrators
  • Pharmacovigilance Systems and Safety Database Professionals
  • Pharmacovigilance Operations and Case Processing Teams
  • System Configuration and Application Support Specialists
  • IT and Application Administrators supporting PV systems
  • Quality Assurance and Computer System Validation Professionals
  • Pharmacovigilance Compliance and Data Management Professionals
  • Anyone responsible for configuring, administering, supporting, or maintaining Oracle Argus Safety systems
📢 Every purchase also includes our FREE companion Advanced Oracle Argus Safety eBook, designed to help you apply principles in real-world pharmaceutical medicine settings.

What you will learn

Understand the advanced features of Oracle Argus Safety, including the Safety Console, system architecture, configuration options, and administrative functions used to manage pharmacovigilance operations.

Learn how to configure users, roles, workflows, case processing settings, product and event configurations, and other system parameters while maintaining appropriate access controls.

Develop knowledge of Argus Safety administration, data management, workflow configuration, business rules, reporting settings, system monitoring, and configuration change control.

Gain practical understanding of system security, audit trails, data integrity, validation considerations, troubleshooting, system maintenance, and best practices for compliant Oracle Argus Safety administration.

Course Syllabus

  1. What sits inside an Argus implementation
  2. Application, database and services
  3. Three environments, one controlled path
  4. Why separate environments matter
  5. A conceptual system map
  6. Multi-tenant (multi-enterprise) Argus
  7. The operating model: who owns what
  8. Key integrations and why they matter
  9. Common errors & inspection risks

  1. What Argus Console is
  2. The main configuration domains
  3. Global versus enterprise configuration
  4. Code lists and business configuration
  5. Why Console governance matters
  6. Who may change what
  7. A Console change, under control
  8. A Console configuration record
  9. Common errors & inspection risks

  1. The Argus organisational model
  2. Groups and roles bundle permissions
  3. Least privilege and the access lifecycle
  4. A user and role assignment
  5. Why this matters in practice
  6. Segregation of duties
  7. Authentication and named accounts
  8. Periodic access review
  9. Common errors & inspection risks

  1. The product configuration hierarchy
  2. Licences link a product to markets
  3. Study configuration
  4. Configuring a new product to go-live
  5. A product and licence record
  6. Why this matters in practice
  7. Downstream dependencies of a new product
  8. Data quality and the product dictionary
  9. Common errors & inspection risks

  1. What a reporting destination is
  2. What a submission profile holds
  3. Destination configuration is not the reporting rule
  4. A reporting destination record
  5. Example destinations, methods and standards
  6. Why this matters in practice
  7. Changes triggered by adding a destination
  8. ALCOA+ and the audit trail on submissions
  9. Common errors & inspection risks

  1. Workflow is a configured sequence of states
  2. Routing rules move cases to the right team
  3. Worklists and action items
  4. The case-state lifecycle
  5. A worklist and routing view
  6. Why workflow and routing config matters
  7. Sequence and timeliness are configured
  8. Segregation of duties and locking
  9. Common errors & inspection risks

  1. Dictionaries in Argus
  2. MedDRA hierarchy and release cycle
  3. Coding configuration in Argus
  4. The MedDRA hierarchy at a glance
  5. Why controlled dictionary upgrades matter
  6. A MedDRA upgrade is a change-control event
  7. Version currency and human governance
  8. MedDRA upgrade under control
  9. Common errors & inspection risks

  1. What reporting rules decide
  2. Auto-scheduling a report
  3. Timeframes and day-zero
  4. Scenario to destination and timeframe
  5. Why reporting-rule config is high-stakes
  6. Rules operationalise the obligation
  7. Positive and negative testing
  8. How a report is auto-scheduled
  9. Common errors & inspection risks

  1. What E2B(R3) is
  2. Message profile configuration
  3. Gateway concepts
  4. E2B submission flow
  5. An E2B and gateway profile
  6. Why the E2B profile matters
  7. Acknowledgements and corrections
  8. Testing end-to-end before go-live
  9. Common errors & inspection risks

  1. Common failure patterns
  2. A structured troubleshooting approach
  3. Data problem versus configuration problem
  4. Symptom to likely layer to first check
  5. Root-cause and CAPA
  6. Why config defects need CAPA, not resubmission
  7. Configuration defects are systemic
  8. Troubleshooting under change control
  9. Common errors & inspection risks

  1. What a compliant audit trail captures
  2. ALCOA+ data integrity in practice
  3. Security: named accounts, least privilege, SoD
  4. An audit trail entry
  5. ALCOA+ elements at a glance
  6. Why access and audit-trail discipline matter
  7. Risk-based audit-trail review
  8. Periodic access review and recertification
  9. Common errors & inspection risks

  1. Change control for every configuration change
  2. The validation lifecycle and GAMP 5
  3. Legacy CSV versus CSA
  4. The change control lifecycle
  5. GAMP category and validation effort
  6. Why this matters in practice
  7. Release management
  8. Emergency changes under control
  9. Common errors & inspection risks

  1. The business continuity plan (BCP)
  2. Manual and contingency procedures
  3. Disaster recovery (DR)
  4. If the system is unavailable
  5. BCP versus DR at a glance
  6. Why this matters in practice
  7. Operational support
  8. Supplier and cloud governance
  9. Common errors & inspection risks

  1. What inspection readiness means
  2. System governance
  3. Configuration lifecycle management
  4. Metrics and KPIs that govern
  5. The inspection-ready evidence set
  6. Why this matters in practice
  7. What inspectors commonly ask
  8. The capstone: seven controlled steps
  9. Common errors & inspection risks

  1. 📘 Bonus: Advanced Oracle Argus Safety eBook (Free with purchase)

Course Benefits

Benefits ebook icon
Free eBook

Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever

Benefits cpd_points icon
CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

Benefits certification icon
Certification

Receive a personal certificate to show your subject knowledge on course completion.

Benefits affordable icon
Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

Benefits flexible icon
Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

Benefits up_to_date icon
Keep Up to Date

You will stay up to date with changes to EU Good Pharmacovigilance Practices, EU CTR/EudraVigilance, ICH E2B(R3), MedDRA versioning, 21 CFR Part 11, EU Annex 11 (including the 2025 draft revision) and GAMP 5 as our training courses are constantly monitored, reviewed and updated.

Benefits industry_experts icon
Learn from Industry Experts

The course content has been developed by pharmacovigilance safety-systems and validation practitioners to ensure learners can configure, administer and govern an Argus-style safety system to current regulatory and good-practice standards.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

Learner Rating & Reviews

4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

Recommended Courses

Device Safety and Vigilance

Device Safety and Vigilance

Professional
£794 hrs4 points
Introduction to Medical Writing

Introduction to Medical Writing

Intermediate
£393 hrs2 points
Oracle Argus Safety Essentials and ICSR Case Processing

Oracle Argus Safety Essentials and ICSR Case Processing

Intermediate
£393 hrs3 points
Medical Writing of Periodic Benefit-Risk Evaluation Report (PBRER)

Medical Writing of Periodic Benefit-Risk Evaluation Report (PBRER)

Intermediate
£392 hrs3 points
Drug Safety - Russian

Drug Safety - Russian

Professional
£794 hrs4 points