Premier Global Compliance Academy • Delhi
Flagship 30-Hour Workshop

Advanced Workshop on Pharmacovigilance Operations

& Career Opportunities

30 Hours Intensive
Offline / In-Person
₹3,540 (incl. GST)

A complete job-ready program covering all PV operations — adverse event monitoring, MedDRA coding, database handling, regulatory frameworks, and career readiness. Delivered by industrial experts using real-world scenarios.

Why This Workshop Exists

The pharmacovigilance industry needs professionals who can operate — not just professionals who have studied. Most academic programs leave a critical gap between what is taught and what the industry actually expects on Day 1.

This 30-hour intensive workshop was built to close that gap completely. You will work through the full PV operations lifecycle — from adverse event identification to regulatory submission — using real-world case scenarios, industry workflows, and the exact decision logic used by drug safety teams worldwide.

When you complete this workshop, you are not just "trained." You are job-ready.

30 Hours

Intensive hands-on training

Offline Mode

In-person classroom training

Industry Experts

Trained by active PV professionals

Real Scenarios

Not simulations — real-world cases

Job-Ready

Certification upon completion

Career Support

Placement guidance included

Workshop Curriculum

8 comprehensive modules spanning 30 hours of intensive training

01

Foundations of Pharmacovigilance & Regulatory Landscape

Topics Covered

PV ecosystem — WHO, ICH, USFDA, EMA, CDSCO
ICH guidelines overview: E2A, E2B(R3), E2C, E2D
Good Pharmacovigilance Practices (GVP) modules
Drug safety obligations across the product lifecycle
Understanding the role of MAH and regulatory authorities
02

Adverse Event Monitoring & ICSR Processing

Topics Covered

ADR identification and spontaneous vs solicited reports
Four minimum valid case criteria
Seriousness and expectedness classification
Case triage, prioritisation, and intake workflows
Data entry standards and completeness checks
03

MedDRA Coding & Medical Terminology

Topics Covered

MedDRA structural hierarchy: SOC, HLGT, HLT, PT, LLT
Coding complex multi-event cases accurately
Primary vs secondary SOC assignment
Version management and quality review standards
Practical coding exercises with real-world cases
04

Database Handling & Data Entry Operations

Topics Covered

Safety database architecture and workflows
Case creation, routing, and workflow management
Data entry quality standards and audit trails
Follow-up processing and case amendments
Database lock procedures and data integrity
05

Adverse Event Assessment & Causality

Topics Covered

WHO-UMC causality assessment methodology
Naranjo algorithm — practical application
Expectedness determination vs reference safety information
Listedness against Company Core Data Sheet (CCDS)
Regulatory-quality narrative writing structure
06

Literature Monitoring & Signal Detection

Topics Covered

PubMed and medical literature screening workflows
Safety data extraction from published literature
Signal detection methods: PRR, ROR, EBGM
Signal evaluation, triage, and escalation logic
Literature surveillance regulatory requirements
07

Regulatory Frameworks & Authority Operations

Topics Covered

USFDA: IND Safety Reports, MedWatch, FAERS
EMA: EudraVigilance, GVP compliance, E2B(R3)
CDSCO: Indian PV Programme, Schedule Y, Form 12A
Aggregate reporting: PBRER/PSUR structure
Multi-regional submission timelines and compliance
08

Career Strategy & Job Readiness

Topics Covered

PV career ladder: DSA to Global PV Head
Resume architecture for drug safety roles
Technical interview mastery: case-based scenarios
LinkedIn positioning for global PV recruitment
Industry hiring patterns and salary benchmarking

Who Should
Attend?

This workshop is built for anyone serious about entering or excelling in the PV domain.

B.Pharm / M.Pharm / Pharm.D Graduates
Life Sciences & Healthcare Graduates
Freshers Targeting PV & Drug Safety Careers
Working Professionals Seeking Career Switch
Regulatory Affairs Aspirants
Clinical Research Professionals Expanding Scope
Hashim Mansoori

Hashim Mansoori

Founder & Director — Global PVA

Active in pharmacovigilance since 2018, Hashim brings deep operational experience across ICSR processing, Argus Safety, MedDRA coding, and regulatory submissions. His workshops emphasize practical, industry-grounded training that produces job-ready professionals — not just certificate holders.

Delivered by Industrial Experts

Workshop Fee

₹3,000

₹3,540

Inclusive of 18% GST

30 hours of intensive, hands-on training
Full PV operations lifecycle coverage
Real-world case scenarios — not simulations
Industry expert-led sessions
Certificate of Completion
Career guidance and placement support

Secure Payment via Razorpay • UPI, Cards, Net Banking

How it works: Add to cart → Complete checkout → Pay via Razorpay → Receive instant registration confirmation. Your seat is confirmed once payment is successful.

Frequently Asked Questions

Organized By

Global Pharmacovigilance
Academy

Advancing practical education in Pharmacovigilance, Drug Safety, and career readiness for the global pharmaceutical industry.