Pharmacovigilance Hands-on Training with MedDRA Coding, Vigilance Tools & AI in Drug Safety + Project Work
Launch Your Career in Drug Safety with Confidence
AI in Pharmacovigilance & Drug Safety
WORK ON PROJECT + 100% PLACEMENT ASSISTANCE
Pharmacovigilance Online Hands-on Training with MedDRA Coding, Vigilance Tools & AI in Drug Safety
Get Hands-On Training in MedDRA - Master the Globally Accepted Medical Coding System for Clinical Research & Drug Safety
With 100% Placement Assistance
STARTS 13th JAN 2026
Looking to build a strong foundation in pharmacovigilance and land a high-demand job in the pharmaceutical or healthcare industry? This hands-on training program is designed to make you industry-ready with real-world projects, expert mentorship, and 100% placement assistance. Whether you're a fresher or a working professional looking to upskill, this program is your gateway into the fast-growing world of drug safety.
- Start Date: 13TH JAN 2026
- Mode: Online (Live + Recorded Sessions)
- Duration: 60 Days
- Project Work: 1 & 2 Months, after completion of training
- Time: 7:00 to 8:00 pm IST
- Level: Beginner to Intermediate
- Ideal For: Life Sciences, Pharma, Biotech Graduates, Freshers, and Working Professionals
Why Choose This Training?
The Pharmacovigilance Hands-on Training Program offers a career-focused, skill-based curriculum that prepares you for success in one of the most in-demand fields of the life sciences industry.
What makes this program unique:
- Learn essential pharmacovigilance concepts with hands-on training in ICSR processing, MedDRA coding, and narrative writing
- Gain exposure to drug safety workflows, regulatory guidelines, and case management systems
- Work on real-world projects designed using freely available datasets, open-source tools, and simulated environments
- Receive 100% placement assistance, including resume building, LinkedIn optimization, and mock interviews
- Get mentored by industry experts and be certified at the end of the program
- Access recorded sessions, assignments, quizzes, and feedback support
Eligibility Criteria
This program is suitable for:
- Students and graduates in Life Sciences, Biotechnology, Pharmacy, and related fields
- Freshers interested in a career in pharmacovigilance or clinical research
- Professionals in the healthcare domain looking to transition into drug safety roles
- Individuals preparing for roles in CROs, pharma companies, and regulatory departments
Career Path After This Program
Pharmacovigilance is a growing industry that offers multiple career opportunities across different sectors:
Industry Sectors:
- Pharmaceutical & Biotech Companies
- Contract Research Organizations (CROs)
- Hospitals & Clinical Trial Units
- Health IT & Drug Monitoring Systems
- Regulatory Affairs Departments
Career Roles You Can Target:
- Drug Safety Associate
- Pharmacovigilance Officer
- ICSR Processor
- MedDRA Coder
- Safety Data Analyst
Check out the curriculum & Course Instructor Detail.
DOWNLOAD BROCHURE
What You'll Learn – Detailed Curriculum
Week 1: Foundations of Pharmacovigilance
Day 1: Introduction to Pharmacovigilance & its Importance
Day 2: Drug Development Lifecycle & PV's Role
Day 3: Types of Adverse Events (AE) and ADRs
Day 4: Classification: Serious vs Non-serious Events
Day 5: AE Reporting Timelines & Workflow
Day 6: Glossary Exercise + Assignment
Day 7: Weekly Quiz + Live Q&A
Week 2: Regulatory Guidelines & Case Processing
Day 8: ICH Guidelines: E2A to E2F Overview
Day 9: Global Regulatory Authorities: USFDA, EMA, CDSCO, WHO-UMC
Day 10: PV Case Processing Lifecycle
Day 11: CIOMS & MedWatch Forms
Day 12: Narrative Writing: Structure + Sample
Day 13: SOP Drafting for AE Reporting
Day 14: Weekly Quiz + LIVE Review
Week 3: MedDRA & Causality Assessment
Day 15: MedDRA Terminology: SOC, PT, LLT
Day 16: Hands-on MedDRA Browser Practice
Day 17: WHO Drug Dictionary Overview
Day 18: Causality Assessment: Naranjo Scale
Day 19: Coding Practice with Fictional Cases
Day 20: Writing Integrated Narratives
Day 21: Weekly Quiz + LIVE Discussion
Week 4: ICSR Compilation & Risk Management
Day 22: ICSR Components and Structure
Day 23: Data Entry Simulation (ICSR Fields)
Day 24: Compilation of ICSRs
Day 25: Introduction to Risk Management Plans (RMPs)
Day 26: Spontaneous vs Solicited Reporting
Day 27: Case Processing Workflow Simulation
Day 28: Vaccine Pharmacovigilance
Day 29: Weekly Quiz + Peer Feedback
Week 5: Software Tools in PV
Day 30: WHO VigiFlow Walkthrough
Day 31: OpenClinica Data Management Basics + Demo
Day 32: Argus Safety: Interface Overview + Demo
Day 33: ArisG Concepts & User Flow + Demo
Day 34: Introduction to SAS in Pharmacovigilance
Day 35: Mock Case Entry + SOP Integration
Day 36: Weekly Quiz + LIVE Tools Recap
Week 6: Signal Detection & Workflow Design
Day 37: Introduction to Signal Detection: PRR, ROR
Day 38: Dummy Data Analysis using Excel
Day 39: Case to Report Workflow Design
Day 40: SOP Development: Safety Unit Protocols
Day 41: LIVE Weekly Review + Readiness Assessment
Week 7: Vigilance Tools & AI In Pharmacovigilance
Day 42: FDA FAERS – Identifying and Analyzing Real-World Adverse Drug Event Patterns(Live DEMO)
Day 43: EMA EudraVigilance – Monitoring Drug Safety Trends(Live DEMO)
Dy 44: VigiAccess – Global Safety Signal Exploration Through WHO Safety Reports(Live DEMO)
Day 45: Future of Pharmacovigilance: AI in Drug Safety Systems
Day 46: Innovative Pharmacovigilance Practices Using AI-Based Tools
Final Assessment
Week 8: Project Work & Career Preparation
Day 47: Project Topic Orientation + Mentor Q&A
Day 48:LinkedIn Optimization & Career RoadMap: Scope, Qualifications, Job roles,
Salary Trends & Skills required"
Day 49-50: Project Briefing + Literature Review (Dataset Work / ICSR Compilation / SOP Draft)+ Report Writing
Day 51: Resume Building + Career Counseling Session
Day 52-55: Mid-Project Review by Mentor
Day 56: Final Compilation + Submission
Day 57-60: Project Presentation (Live) + Mock Interview + Interview Skills guidance
PROJECT TOPICS
Project Work: 1 Month Duration
Topics
-
Systematic Review of Case Reports on Rare ADRs from PubMed/Case Reports Journals
-
Pick few rare MedDRA PT – Find which drugs most report it in VigiAccess
-
Overview of Clinical Trial Terminations Due to Safety Issues
-
ICSR Compilation with Dummy Data for Pharmacovigilance Training
-
Off-Label Drug Safety Monitoring Using MedDRA
Project Work: 2 Month Duration
Topics
-
Analysis of Drug Withdrawals in the Last Decade Using WHO/FDA Alerts / Recent Drug Withdrawals
-
Pharmacovigilance (PV) Analysis of Adverse Events in a Clinical Trial
-
Polypharmacy Adverse Event (AE) Risk Stratification Using MedDRA
-
Disproportionality Analysis of ADRs Using FAERS
-
Signal and Trend Analysis of Adverse Drug Reactions Using VigiAccess
-
Safety Monitoring of Drugs Used in Special Populations (Pregnancy / Elderly / Pediatrics)
-
Comparative Safety Analysis of Drugs Within the Same Class
-
Serious vs Non-Serious ADR Patterns and Outcomes Analysis
Tools You'll Learn
| Tool | Purpose | Access Type |
|---|---|---|
| MedDRA Browser | ADR Coding | Free |
| WHO VigiFlow | Case Reporting (for demo use) | Public Demo |
| OpenClinica | Clinical Data Entry | Open Source |
| Argus Safety | Case Management System | Video Walkthroughs / Simulations |
| ArisG | Adverse Event Reporting | Public Demos / Conceptual Overview |
| Excel / R | Signal Detection & Data Analysis | Free/Open Source |
Important Note:
Due to licensing restrictions, access to commercial tools like Argus and ArisG may not be available. However, we ensure all learning and projects are fully executable using:
-
Open-source alternatives
-
Public demo versions
-
Simulations and video-based walkthroughs
Project Topics
These projects are designed to provide real-world exposure using free tools:
-
Signal Detection from Simulated ADR Dataset
Tools: Excel / R
Analyze dummy data to identify safety signals. -
ICSR Compilation, MedDRA Coding & Narrative Writing
Build and process five fictional case reports end-to-end. -
SOP Development for a PV Unit
Create standard operating procedures for AE handling and regulatory submission.
What You Receive
- 60 Days of Full Training with Project Work
- One-on-One Mentoring and Peer Feedback
- Resume and LinkedIn Optimization
- Mock Interviews with Expert Feedback
- Experience Letter
- 100% Placement Assistance
- Certification Ceremony & Career Counseling
Enroll Now & Jumpstart Your PV Career
Whether you're starting out or planning a career switch, this program is your stepping stone to success in pharmacovigilance.
Seats are limited. Enroll today and unlock your career potential in drug safety and regulatory affairs.
Need help deciding? Contact our counselors — we’re here to help you choose the right path forward.