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Pharmacovigilance Training with Argus Safety

Build practical pharmacovigilance skills through hands-on training in ICSR processing, adverse event reporting, MedDRA and WHO Drug coding, aggregate reports, safety signals, and Oracle Argus Safety workflows.

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Who this is for

Pharmacy, life-sciences, nursing, healthcare, and medical graduates targeting PV and drug safety roles
Candidates preparing for Drug Safety Associate, PV Associate, ICSR Specialist, or Safety Data Analyst roles
Professionals who want hands-on Oracle Argus Safety and case processing exposure

Outcomes

Understand pharmacovigilance regulations, safety reporting pathways, and PV department workflows
Process ICSRs from intake through triage, data entry, duplicate check, QC, medical review, and submission
Assess seriousness, causality, expectedness, listedness, and reportability
Use MedDRA and WHO Drug coding concepts for adverse events and suspect products
Work through Oracle Argus Safety configuration, case tabs, regulatory reports, narratives, and live practice cases

Tools and topics

Core concepts and platforms covered through examples, assignments, and interview preparation.

Oracle Argus SafetyArgus ConsoleICSRMedDRAWHODDPSURPADERPBRERCTPRDSUR

Course content

Structured modules for practical learning.

Clinical Trial and PV Foundations

End-to-end clinical trial process, phases, study types, and designs
CRO model, trial team roles, and clinical research responsibilities
Protocol, Investigator's Brochure, Informed Consent Form, and CRF live examples
ICH-GCP, SOPs, GVP, and regulatory expectations
Medical coding dictionaries and safety documentation basics

Pharmacovigilance Overview

History, introduction, and overview of pharmacovigilance
Regulatory authorities in India, USA, Europe, and other regions
Spontaneous reporting, active surveillance, and cohort event monitoring
PV in clinical trials and post-marketing surveillance
PV departments, responsibilities, and workflow handoffs

Adverse Events and Safety Reporting

Adverse event definitions and types
Serious adverse events and special reporting scenarios
Sources of adverse event reporting and reporting forms
Minimum criteria for a valid case
Expedited reporting timelines and regulatory submission concepts

ICSR Case Processing

ICSR lifecycle and case intake workflow
Book-in, triage, data entry, duplicate check, validation, and routing
QC review, medical review, follow-up, action items, and contact logs
Case priority, case numbering, workflow states, and validation errors
Narrative writing and safety case documentation

Assessment and Coding

Seriousness, causality, expectedness, listedness, and reportability assessments
MedDRA coding for adverse events
WHO Drug Dictionary coding for products
Coded term review and coding quality checks
Safety signal basics, signal detection, and risk management overview

Aggregate and Periodic Reports

Aggregate reporting concepts and regulatory use
PSUR, PADER, PBRER, CTPR, and DSUR overview
ICH PV guidelines E2A to E2F
Regulatory report scheduling, approval, submission, and tracking
Local affiliate model and report routing concepts

Oracle Argus Safety Configuration

Oracle Argus Safety Database introduction
Argus Console and business process overview
Product, license, study, site, user, group, workflow, and case priority configuration
Code lists, validations, numbering, and system setup concepts
Argus database navigation and practical system orientation

Oracle Argus Case Processing Practice

Argus case search, book-in, data entry, and case tab workflow
ICSR processing in Argus
Regulatory report generation, scheduling, approving, and submitting
Live spontaneous and clinical trial case processing
End-to-end Argus Safety project and interview scenarios

Potential recruiters

Training connected to pharma, CRO, healthcare data, and technology roles.

FAQs

Pharmacovigilance questions

Quick answers for candidates evaluating this course before applying.

Who is the Pharmacovigilance course best for? +

Pharmacy, life-sciences, nursing, healthcare, and medical graduates targeting PV and drug safety roles Candidates preparing for Drug Safety Associate, PV Associate, ICSR Specialist, or Safety Data Analyst roles Professionals who want hands-on Oracle Argus Safety and case processing exposure

What will I learn in Pharmacovigilance? +

Understand pharmacovigilance regulations, safety reporting pathways, and PV department workflows Process ICSRs from intake through triage, data entry, duplicate check, QC, medical review, and submission Assess seriousness, causality, expectedness, listedness, and reportability Use MedDRA and WHO Drug coding concepts for adverse events and suspect products Work through Oracle Argus Safety configuration, case tabs, regulatory reports, narratives, and live practice cases

Is this course instructor-led? +

Yes. Clini Data Curve courses are positioned as instructor-led live online training with recordings, assignments, assessments, resume preparation, mock interviews, and placement assistance.

How do I apply for this course? +

Use the Apply Now button or enquiry form to share your details and selected course. The team can guide you on batches, fit, and next steps.

Need guidance?

Talk to Clini Data Curve before choosing your course.

Share your background and career goal. The team can help you choose the right CDM, pharmacovigilance, SAS Clinical, CRA, medical coding, or clinical research path.

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