Master the fundamentals of pharmacovigilance, adverse event reporting, and clinical trial safety monitoring — with a proctored final test that generates your Cliniaura Score.
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By Dr. Sunita Mehta · Senior PV Consultant, ex-Parexel
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Click to preview first lesson
₹4,999₹7,999Save 37%
🔥 42 students enrolled this week
This course includes
📹 24 hours HD video lectures
📝 8 graded assignments
🏆 Proctored final test
📜 Verified certificate
♾ Lifetime access
📱 Mobile & desktop access
🛡 30-day money-back guarantee
What you'll learn
✓ICH E2A/E2B adverse event reporting standards
✓CIOMS forms and MedDRA coding
✓Periodic Safety Update Reports (PSURs)
✓Signal detection and benefit-risk assessment
✓Clinical trial safety monitoring procedures
✓GVP modules for EU/India compliance
✓FDA 21 CFR Part 312 safety reporting
✓Working with safety databases (Argus/ARISg)
Requirements
B.Pharm, M.Pharm, B.Sc Life Sciences, or equivalent
No prior clinical research experience needed
Basic computer literacy and internet access
About this course
This is India's most comprehensive pharmacovigilance course, built with input from senior PV professionals at Parexel, ICON, and Syneos Health. Over 24 hours of structured video content, you will progress from understanding basic adverse event concepts to mastering regulatory submissions and signal detection workflows. The course concludes with a full-length proctored final test — administered under AI-monitored conditions — whose result directly feeds into your Cliniaura Score, which is visible to all verified employers on the platform.
8 modules · 24 hours · 48 lessons
Module 1: Pharmacovigilance Foundations
6 lessons · 2.5 hrs
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What is Pharmacovigilance? History & Scope18 min
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Adverse Events vs Adverse Reactions22 min
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Causality Assessment Methods25 min
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Module 1 Quiz15 min
Module 2: Adverse Event Reporting
7 lessons · 3 hrs
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ICH E2A: Definitions & Reporting Timelines30 min
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CIOMS Forms — Filling & Submission28 min
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Assignment: CIOMS Form Completion45 min
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Module 2 Quiz20 min
Module 3: MedDRA Coding
5 lessons · 2.5 hrs
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MedDRA Hierarchy Overview20 min
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Coding AEs: PT, HLT, SOC Selection32 min
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Module 3 Quiz20 min
Module 4: Periodic Safety Reports (PSURs)
6 lessons · 3 hrs
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ICH E2C(R2): PSUR Structure25 min
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Assignment: PSUR Executive Summary60 min
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Module 4 Quiz15 min
Modules 5–8: Signal Detection, GVP, Trial Safety, Final Test
24 lessons · 13 hrs
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Signal Detection — Disproportionality Analysis28 min
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GVP Modules for EU Compliance35 min
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CDSCO / India PV Guidelines22 min
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🔒 Proctored Final Test (Cliniaura Score)90 min
4.8
★★★★★
312 ratings
5 ★
78%
4 ★
15%
3 ★
5%
2 ★
1%
1 ★
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PR
Priya Rao
March 2026 · Score 88
★★★★★
The CIOMS mock assignment alone was worth the fee. Very practical content — nothing theoretical for the sake of it. The proctored test is tough but fair, and my Cliniaura Score of 88 helped me land Parexel within 3 weeks.
AK
Arjun Kulkarni
February 2026 · Score 79
★★★★★
I had zero clinical research background. The instructor explains regulatory concepts in a way that actually makes sense. Module 4 on PSURs is exceptional.
NP
Neha Patil
January 2026 · Score 74
★★★★☆
Best-structured PV course at this price point. Would have liked more hands-on Argus database exercises, but overall the content depth is excellent for a beginner.