Master Pharmacovigilance with Practical Argus Training
This program provides a complete grounding in clinical research and pharmacovigilance — from regulatory guidelines and safety case management to Oracle Argus hands-on practice, aggregate reporting and signal management. Designed for job-readiness across pharma, CROs and regulatory bodies.
Program Curriculum
Module 1: Introduction to Clinical Research & Pharmacovigilance
- Clinical Research Overview: Drug Discovery to Submission
- Clinical Research Organizations (CROs) / Contract Research Organizations
- Basics of Clinical Research and Pharmacovigilance (including job opportunities and domains)
- Overview of Regulatory Guidelines: ICH, GMP, GCP, HIPAA, CIOMS, CDSCO, etc.
- Scope of Pharmacovigilance
Module 2: Pharmacovigilance Foundations
- Pharmacovigilance Process and Regulations
- Different Types of Safety Reports
- Phases of Clinical Trials
- Adverse Events (AEs) and Types
- Sources of Adverse Event Reporting
- Types of AE Reporting Forms
- Expedited Reporting and Timelines
Module 3: Safety Case Management
- Assessing Expectedness, Labeledness, Listedness
- Labeled vs. Listed
- Company Core Data Sheet (CCDS) & Company Core Safety Information (CCSI)
- Departments working in Pharmacovigilance
- Roles & Responsibilities of Case Receipt Unit
- Four Factors for a Reportable Case
- Seriousness Criteria of Adverse Events
- Causality Assessment
Module 4: Safety Databases & Medical Coding
- Introduction to Safety Databases (Argus, Arisg, Clinevo, PVEdge, etc.)
- Introduction to MedDRA and WHO-DD
- Narrative Writing for Safety Cases
- Case Quality Check, Medical Review, and Submission
- Reconciliation Activities
- Regulatory Intelligence
Module 5: Practical Training on Oracle Argus
- Oracle Argus Safety Database End-User Training
- Data Entry Training
- Case Book-in Process
- Worklist Intake & Training (New, Open, Ongoing Cases)
- Case Processing: General Case Form (Patient, Product, Event, Analysis, Activities, Additional Info)
- Regulatory Reports Handling
- Case Forwarding / Return
- Medical Review & Coding Review
- E2B Validation
- Data Collection & Processing (from multiple sources)
- Case Initiation → Data Entry → Coding → Labeling → Narrative Writing → QC → Medical Assessment
Module 6: Advanced Database Concepts
- Oracle Argus Data Structure
- Data Mapping (Front-End Fields to Backend Table Columns)
Module 7: Periodic & Aggregate Reporting
- Periodic Safety Update Reports (PSUR)
- History and Rationale
- Changes under new EU PV Legislation (vs. current requirements)
- Format & Content
- Planning & Writing
- Reference Safety Information
- Exposure Data Calculation
- Data Gathering & Evaluation
- Regulatory Aspects
- Other Regulatory Reports: PADERs, PSUR/PBRER, IND AR/ASR, ACO, CSR, DSUR
Module 8: Signal & Risk Management
- Signal Detection Process and Methods
- Risk Management Plans
Module 9: Practical Argus Case Handling
- Data Entry for all types of ICSRs (Spontaneous, Clinical Trials, Literature, Regulatory Authority Cases)
Module 10: Assessments
- Assessment 1 – Written Examination
- Assessment 2 – Applied Knowledge Test
- Case Study – Practical Argus Data Entry Exercise
Program Benefits
Hands-on Argus Practice
Practical exercises in Argus including case book-in, data entry, coding review, and E2B validation.
Regulatory Know-How
Learn global PV regulations, expedited reporting timelines and aggregate reporting requirements.
Career Support
Resume guidance, interview prep and connections with hiring partners in pharma and CROs.
What You Will Learn
- Fundamentals of clinical research and pharmacovigilance.
- How to handle and process safety cases end-to-end in Oracle Argus.
- MedDRA coding and narrative writing for ICSRs.
- Prepare and validate regulatory submissions (E2B, PSUR, PADER, DSUR).
- Perform signal detection and contribute to risk management plans.
- Map front-end fields to backend data structures for accurate reporting.
- Conduct quality checks, reconciliation and prepare audit-ready documentation.
Career Pathways & Job Roles
After finishing this program, common roles you can apply for:
- Pharmacovigilance Associate / Safety Case Processor
- Drug Safety Specialist
- MedDRA Coder
- Aggregate Reporting Analyst
- Signal Detection Analyst
- PV Quality & Compliance Analyst
- PV Data Reconciliation Specialist
- PV Database Administrator (entry-level)
Employers
Pharmaceutical companies, CROs, regulatory agencies and PV service providers.
Career Growth
Advance from case processor → PV specialist → manager → head of PV or safety physician roles (with experience).
Salary Outlook
Competitive salaries with steady growth as you gain database and regulatory experience.
Assessments & Capstone
- Regular quizzes and module-wise practical checks.
- Written examinations and applied knowledge tests.
- Capstone: end-to-end Argus case handling project with mentor feedback.
Frequently Asked Questions
Do I need prior experience?
No. The program starts from fundamentals and builds hands-on skills in Argus and regulatory reporting.
Will I get placement support?
Yes — resume help, mock interviews and introductions to partner employers.
Ready to begin your Pharmacovigilance journey?
Enroll now for practical Argus training, regulatory expertise and placement guidance.