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About

Oracle Argus Safety is widely used by pharmacovigilance organisations to manage Individual Case Safety Reports (ICSRs), support safety case processing, and facilitate regulatory reporting throughout the product lifecycle. Effective use of the system requires an understanding of both pharmacovigilance principles and the structured workflows used to capture, assess, review, and report safety information.
This PV Systems – Oracle Argus Safety Essentials and ICSR Case Processing Training Course & Certification provides comprehensive knowledge of Oracle Argus Safety fundamentals, ICSR intake and data entry, case triage, patient and reporter information, suspect products, adverse events, medical history, coding, seriousness and expectedness assessment, causality, duplicate searches, narratives, follow-up, quality review, regulatory reporting workflows, audit trails, and data integrity. Upon successful completion, learners receive a certification demonstrating their understanding of Oracle Argus Safety and essential ICSR case processing practices.

Who Should Enrol?

  • Pharmacovigilance and Drug Safety Professionals
  • ICSR Case Processing Specialists
  • Safety Database and Oracle Argus Users
  • Medical Reviewers and Safety Physicians
  • Pharmacovigilance Quality and Compliance Professionals
  • Regulatory Reporting and Safety Operations Teams
  • Clinical Research and Drug Development Professionals
  • Anyone seeking to develop practical knowledge of Oracle Argus Safety and ICSR case processing
📢 Every purchase also includes our FREE companion Oracle Argus Safety Essentials & ICSR Case Processing eBook, designed to help you apply principles in real-world pharmaceutical medicine settings.

What you will learn

Understand the fundamentals of pharmacovigilance case processing, Oracle Argus Safety architecture, workflows, and the role of safety databases in managing Individual Case Safety Reports (ICSRs).

Learn how to enter, validate, triage, assess, and process ICSR data in Oracle Argus Safety, including patient, reporter, suspect product, event, and medical history information.

Develop knowledge of case assessment, seriousness, expectedness, causality, duplicate searching, coding, narrative preparation, follow-up, and quality review within the ICSR workflow.

Gain practical understanding of regulatory reporting workflows, case routing, expedited reporting timelines, quality checks, audit trails, data integrity, and best practices for compliant ICSR case processing.

Course Syllabus

  1. What pharmacovigilance is
  2. The PV system and its quality system
  3. Where a safety database sits
  4. Key roles in the PV system
  5. What Argus is
  6. What Argus is not
  7. What Argus does vs what remains human judgement
  8. A tour of Meridian's PV system
  9. Argus support mapped to obligations
  10. Why this matters in practice
  11. Common errors & inspection risks

  1. A conceptual map, not the real UI
  2. The Case Form at a glance
  3. What each Case Form section is for
  4. The Worklist and Action Items
  5. Workflow states and routing
  6. How routing works
  7. The end-to-end ICSR lifecycle
  8. Lifecycle stage to Case Form and role
  9. Configuration vs case work
  10. Why this matters in practice
  11. Common errors & inspection risks

  1. Valid vs invalid at intake
  2. From receipt to a booked case
  3. Source types you will meet
  4. Spontaneous & solicited: how each is triaged
  5. Literature & clinical-trial: how each is triaged
  6. Booking in: the initial case record
  7. Clinical-trial SAE intake & source attribution
  8. Literature-case intake
  9. Duplicate check at intake
  10. Why this matters in practice
  11. Common errors & inspection risks
  12. Day-zero at a glance

  1. Primary source and the reporter hierarchy
  2. Establishing primacy between sources
  3. Identifiable patient: what counts
  4. Reporter and patient can be the same
  5. The Patient / Reporter tab
  6. Parent-child linking
  7. Confidentiality and data-privacy handling
  8. Data quality of demographics
  9. Reporter vs patient roles
  10. Why this matters in practice

  1. Suspect vs concomitant vs interacting
  2. Drug characterisation
  3. Dose regimen, route, dates and indication
  4. Suspect vs concomitant in the Cardizal case
  5. The Products / Dosage tab
  6. Dechallenge and rechallenge
  7. Medical history and concurrent conditions
  8. Event context that aids assessment
  9. Dechallenge / rechallenge outcomes
  10. Why this matters in practice
  11. Common errors & inspection risks

  1. Adverse event vs adverse drug reaction
  2. The six seriousness criteria
  3. Other medically important events (IME)
  4. 'Severe' is not 'serious'
  5. Expectedness vs listedness
  6. Causality: reporter vs company
  7. Which reference document applies?
  8. Seriousness, expectedness, causality flow
  9. The Analysis / Events assessment
  10. When to escalate to medical review
  11. Common errors & inspection risks

  1. What MedDRA is and who maintains it
  2. The five hierarchy levels
  3. Worked example: coding 'heart attack'
  4. Primary vs secondary SOC (multi-axiality)
  5. Code to the most specific LLT
  6. Coding a term in the browser
  7. Term-selection Points to Consider
  8. Standardised MedDRA Queries (SMQs)
  9. MedDRA versioning at a glance
  10. Why the case version matters
  11. Why this matters in practice
  12. Common errors & inspection risks

  1. Purpose of the narrative
  2. Narrative-writing rules
  3. How to structure a narrative
  4. Before / after: Cardizal angioedema (Case B)
  5. Hallmarks of a good narrative
  6. The narrative on the case form
  7. The role of medical review
  8. Company assessment and sign-off
  9. Who assesses what
  10. Reconciling narrative to source documents
  11. Why this matters in practice
  12. Common errors & inspection risks

  1. Managing follow-up information
  2. When follow-up is 'significant'
  3. Upgrading and downgrading seriousness
  4. Follow-up on the case record
  5. Nullification vs amendment
  6. Detecting duplicates
  7. Deterministic, probabilistic and EudraVigilance
  8. Case linking
  9. Nullify, amend or link?
  10. Why this matters in practice
  11. Common errors & inspection risks

  1. What case QC checks
  2. The QC dimensions
  3. Case workflow states
  4. Routing on QC pass or fail
  5. The QC worklist and checklist
  6. Locking a case and why
  7. Case closure versus archiving
  8. Case-level quality metrics
  9. Reconciliation of source to database
  10. Closure and lock at a glance
  11. Why this matters in practice
  12. Common errors & inspection risks

  1. Four questions that decide reportability
  2. The reportability decision path
  3. Day zero: starting the clock
  4. Expedited timelines at a glance
  5. The legal duty versus Argus scheduling
  6. What E2B(R3) is
  7. Main E2B(R3) data-element sections
  8. Nullification, amendment and acknowledgement
  9. Gateways and the FDA transition
  10. Transmission status: an E2B report pane
  11. Why this matters in practice
  12. Common errors & inspection risks

  1. ALCOA+ applied to case processing
  2. Good Documentation Practice at case level
  3. The audit trail: what it must capture
  4. Reading an audit trail entry
  5. Case-processing compliance metrics
  6. Using metrics well
  7. Reconciliation: source against database
  8. What an inspector looks for
  9. Inspector question and where the answer lives
  10. How a case processor prepares
  11. Why this matters in practice
  12. Common errors & inspection risks

  1. 📘 Bonus: Oracle Argus Safety Essentials & ICSR Case Processing eBook (Free with purchase)

Course Benefits

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Free eBook

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

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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.

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Certification

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

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Affordable

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

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Flexibility

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

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Keep Up to Date

You will stay up to date with changes to ICH E2A, E2B(R3) and E2D, EU Good Pharmacovigilance Practices, MedDRA versioning, FDA FAERS/21 CFR 314.80 and MHRA guidance as our training courses are constantly monitored, reviewed and updated.

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Learn from Industry Experts

The course content has been developed by pharmacovigilance and safety-systems practitioners to ensure learners can process, assess and quality-check ICSRs to current regulatory and good-practice standards.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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