Certification Course
Pharmacovigilance Certification
Master drug safety operations, adverse event case processing, signal detection, and global PV regulations. Join the industry with the skills employers actually look for.
2 Month Course Live Online Classes Industry Certificate
One-time enrollment fee
₹7,500
Duration
2 MonthsBatch Size
Small BatchesMode
Online Live ClassesCertificate
On CompletionPlacement
100% AssistanceRating
4.9 / 5Adverse Event Case Processing
MedDRA Coding
PSUR / PBRER Writing
Signal Detection
Mock Interviews & Placement
Curriculum
What You'll Learn
A structured 2-month curriculum designed with industry professionals, covering everything you need to start your PV career.
Module 1
Introduction to Pharmacovigilance
- History and evolution of pharmacovigilance globally
- Importance of drug safety and patient protection
- Key regulatory bodies: WHO, EMA, USFDA, CDSCO
- Definitions: AE, ADR, SAE, SUSAR, signal
Module 2
Regulatory Framework
- ICH E2A, E2B, E2C, E2D, E2E guidelines
- EU pharmacovigilance legislation (DIR 2010/84/EU)
- US FDA MedWatch and 21 CFR Part 312/314
- Indian PvPI (Pharmacovigilance Programme of India)
Module 3
Individual Case Safety Reports (ICSRs)
- Case intake and triage
- MedDRA coding fundamentals
- Causality assessment methods (WHO-UMC, Naranjo)
- Expedited and periodic reporting timelines
Module 4
Signal Detection & Risk Management
- Signal detection methods: disproportionality analysis
- Safety signal evaluation and management
- Risk Management Plans (RMP) overview
- Minimisation measures and effectiveness
Module 5
Periodic Safety Reports
- PSUR / PBRER structure and content
- Development Safety Update Reports (DSUR)
- Benefit-risk assessment framework
- Aggregate report submission timelines
Module 6
Career & Placement Preparation
- PV job roles and career paths
- Resume building for pharma/CRO jobs
- Mock interview sessions with industry experts
- Direct recruiter connects and job referrals
Course Outcomes
- Process Individual Case Safety Reports (ICSRs) confidently
- Apply MedDRA coding in real adverse event case handling
- Understand global regulatory requirements (EU, US, India)
- Perform causality assessment using standard methodologies
- Interpret and contribute to PSUR/PBRER writing
- Clear pharmacovigilance interviews at leading pharma companies
Who Is This For?
- B.Pharm / M.Pharm graduates seeking pharma industry careers
- MBBS / BDS / Nursing professionals exploring non-clinical roles
- Life sciences graduates (Biotechnology, Microbiology, Biochemistry)
- Working professionals looking to transition into drug safety
- Clinical Research Associates wanting to expand their expertise
Not sure if this is right for you?
WhatsApp us and we'll guide you →FAQ
Frequently Asked Questions
Batch Starting Soon
Start Your PV Career Today
₹7,500 one-time fee. 2 months. 100% placement assistance. Limited seats — enroll now.
✉ medizeninstitutevigilance@gmail.com ·