Post Graduate Diploma Powered by Saffron

Pharmacovigilance

Master drug safety, adverse event reporting, and post-marketing surveillance — and build a career at the forefront of patient protection.

🌍 WHO Guidelines 📋 ICH / GVP 🔬 CIOMS 📊 MedDRA
Flexible Duration
Online Live Classes
Placement Assistance
Drug Safety· Adverse Event Reporting· Signal Detection· Regulatory Submissions

About the Programme

With the growing emphasis on Pharmacovigilance and Pharmacoepidemiology, the pharmaceutical industry is witnessing a significant rise in demand for trained professionals who can manage post-marketing surveillance activities.

Saffron's Post Graduate Diploma in Pharmacovigilance has been designed by industry experts, ensuring comprehensive coverage of all key functional areas — equipping participants with updated theoretical knowledge and practical insights into modern PV practices.

These programmes are gaining recognition worldwide as an excellent pathway to careers in drug safety, regulatory affairs, and related domains.

Enhanced industrial training and skill development

Practical exposure to industry regulations, guidelines and workflows

Strong foundation in epidemiological and statistical principles

Development of effective scientific communication skills

Programme Curriculum

Six progressive modules with hands-on workshops and real-world simulations

1

Foundations & Real-World Context

History, case studies, and core PV terminologies

Introduction to PV Thalidomide & Sulfanilamide AE / ADR / SAE / SUSAR Mock AE Reporting
2

Regulatory Framework & Reporting Systems

WHO, ICH, CIOMS, GVP guidelines — hands-on ICSR practice

GVP Guidelines ICSR Processing MAH Responsibilities PV Software Demo
3

Causality Assessment & Data Coding

Dechallenge/rechallenge, coding tools, and real case workshops

WHO UMC Scale Naranjo Scale MedDRA WHO COSTART ART Dictionary
4

ADR Reporting & Aggregate Data Handling

Multi-country ADR systems and aggregate safety report writing

DSUR PSUR PADER PBRER Aggregate Data Analysis
5

Case Studies & Real-Life Simulations

End-to-end PV data lifecycle management and signal detection

Hands-on Report Writing PV Data Lifecycle Signal Detection PV Databases
6

Industry Insights & Career Preparation

Guest speakers, mock interviews, resume workshops, and final project

Guest Lectures Mock Interviews Resume Building Certification Exam

Programme Deliverables

Everything included in your learning journey

Comprehensive Study Material

Well-structured printed study material for all modules, aligned with current industry expectations.

Module-wise Assignments

Continuous evaluation through assignments ensuring regular guidance and skill development.

Interactive Live Sessions

Online live or interactive classes covering all key topics with flexibility for participants.

Weekend Classes

Part-time weekend classes with dedicated doubt-clearing sessions before final examinations.

Assessment & Skill Enhancement

Regular assessments to strengthen competencies and prepare for real-world application.

Expert Faculty Support

Experienced Saffron faculty ensure every module is explained clearly and practically.

Certification

Examination & Certification

Your path to a recognised post-graduate qualification

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Module Assignments

Submit module-wise assessment assignments on time throughout the programme.

💻

Online Examination

Appear for an online examination at the end of the programme.

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PG Diploma Award

Awarded by the Faculty of Clinical Research & Drug Safety, Saffron Institute.

Career Opportunities

Roles you can pursue after completing the programme

Pharmacovigilance Expert

Drug Safety Associate

Drug Safety Specialist

Clinical Operations Professional

Placement Assistance & Corporate Relations

Saffron's dedicated placement cell led by senior HR and Talent Acquisition professionals actively supports participants with resume development, interview preparation, and industry connections.

Professionals from leading companies include:

Novartis Parexel Makrocare Genpact Biocon Wipro TCS Abbott APCER Life Sciences Jubilant Life Sciences Wockhardt IQVIA Glenmark Cipla Sun Pharma Zydus Cadila

Eligibility

Graduates and Post-Graduates in Medical and Healthcare fields are eligible:

MBBS BDS BAMS BHMS Pharm D M.Pharmacy B.Pharmacy

Programme Mode

Online Mode — Registrations Open

Programmes Available

PG Diploma · Executive Diploma · Professional Certification

Programme Fee

Professional Certification

Full Time / Part Time · Online Live Classes

₹55,000

or $598 USD

6 comprehensive curriculum modules
Hands-on PV software & case simulations
Placement assistance & corporate connections
Postgraduate Diploma certificate