Drug safety from case intake to regulatory reporting.

Live instructor-led Pharmacovigilance training (2 months, 1.5 hr/day, Mon–Fri). Hands-on with Oracle Argus Safety. FDA / EMA / WHO regulatory frameworks, ADR reporting, aggregate reports, signal detection. Real case studies throughout.

• Duration: 2 months (1.5 hr/day, Mon–Fri)
• Level: Beginner → Job-ready
• Live instructor-led: ₹29,000
• Self-paced: ₹10,000

Pharmacovigilance curriculum

1. Module 01: PV Foundations

   Pharmacovigilance principles, FDA, EMA, WHO and CDSCO regulations.

2. Module 02: ICSR Intake

   Sources, validity criteria, triage workflow, seriousness assessment.

3. Module 03: Argus Safety Hands-On

   Case entry, narrative, quality-control, expedited vs routine.

4. Module 04: MedDRA Coding

   LLT → PT → HLT → SOC, coding conventions, special situations.

5. Module 05: Narrative Writing

   Medical review, causality, company comments, labelling.

6. Module 06: Aggregate Reports

   PSUR, PBRER, DSUR — structure, content, interval handling.

7. Module 07: Signal Detection

   Disproportionality, EudraVigilance, risk-management plans.

8. Module 08: Interview & Placement Prep

   Resume review, mock PV interviews, direct referrals.