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Master ICSR processing, MedDRA coding, safety databases, and global regulatory requirements for drug safety careers in just 8-10 weeks
Job-focused training for Drug Safety Associate, ICSR Processor, and Pharmacovigilance Executive roles
This intensive 8-10 week diploma provides practical, hands-on training in pharmacovigilance operations with a focus on immediate job readiness. Through live sessions, recorded content, assignments, and real-world case studies, you will gain the exact skills needed for entry-level positions in drug safety.
What makes our Pharmacovigilance Diploma program exceptional
Designed specifically for Drug Safety Associate, ICSR Processor, and PV Executive roles
Real ICSR processing with MedDRA coding, narrative writing, and safety database practice
Learn from Drug Safety Associates, PV Managers, and QPPVs currently working in the industry
Comprehensive placement support with pharmaceutical companies, CROs, and BPOs
Introduction to Argus, ArisG, Veeva Vault Safety, and LifeSphere Safety databases
PV-specific job-readiness module with resume workshops and mock interviews
Total Modules: 12 | Format: Live + Recorded + Assignments + Case Studies
What is PV? Why does it matter? History & evolution of PV, role in clinical research & post-marketing, stakeholder roles (MAH, CROs, HA, sites), drug safety workflow overview
ICH E2 Series overview, WHO, EMA, FDA, MHRA safety guidelines, CDSCO & Indian PVPI system, post-marketing surveillance (PMS), black box warnings, REMS programs
What is an ICSR? Minimum criteria for a valid case, reporter to sponsor to authority flow, case intake channels, triage process in case handling
AE, ADR, SAE, SUSAR definitions, expected vs unexpected events, seriousness criteria (6-point evaluation), causality assessment basics, role of CRC/PV teams
Introduction to MedDRA, hierarchy (SOC, HLGT, HLT, PT, LT), coding rules & conventions, hands-on coding of sample AEs manually, version updates
Structure of a narrative, why narratives matter, writing style: clear, factual, unbiased, hands-on writing of simple + complex case narratives, checklist for quality
Data entry in safety databases, sections of a safety case, medical history, lab values, suspect drugs, query management, case booking, follow-up & closure
PSUR/PBRER basics, DSUR overview, PADER, CO & CIOMS reports, line listings, when aggregate reporting is required
What is a safety signal? QPPV role in EU, signal identification methods, Risk Management Plan (RMP) basics, post-marketing risk minimization measures
PV audits & inspections, common findings in PV audits, CAPA creation, data integrity & ALCOA+, compliance expectations for associate-level staff
Overview of global PV systems: Argus, ArisG, Veeva Vault Safety, LifeSphere Safety, AI in safety case processing, automation tools (triage, coding, duplicate checks)
Resume building for PV roles, PV interview questions (Beginner to Advanced), case-based interview simulations, email etiquette for safety communication, real-world case studies
Complete the form below to enroll in our Program
Master pharmacovigilance operations skills for high-demand roles in pharmaceutical, biotech, CRO, and BPO industries.
After completing this program, you will be able to:
Gain comprehensive knowledge of drug safety processes from case intake to regulatory reporting
Identify and classify adverse events according to seriousness and expectedness criteria
Apply MedDRA terminology to code adverse events according to industry standards
Handle individual case safety reports from intake through to closure with supervision
Create accurate, unbiased, and comprehensive narratives for safety cases
Understand ICH, FDA, EMA, and CDSCO guidelines for pharmacovigilance operations
Confidently approach job interviews with practical knowledge and industry insights
Complete end-to-end ICSR processing including data entry, coding, and narrative writing
Comprehend PSUR/PBRER requirements and when aggregate reporting is needed
Understand safety signal identification and basic risk management principles
High-demand roles you can pursue after completing this diploma
Process ICSRs, perform data entry, coding, and follow-up activities in safety databases
Handle individual case safety reports from intake through to regulatory submission
Support PV operations including case processing, quality checks, and documentation
Enter safety data into pharmacovigilance databases with accuracy and compliance
Support safety database operations and maintain data quality standards
Handle drug safety inquiries and adverse event reports in medical information departments
Train new staff on pharmacovigilance processes, MedDRA coding, and safety databases
Support safety monitoring in clinical trials and post-marketing surveillance
Start your pharmaceutical career journey today