Clinical Development Sciences

PROGRAM DURATION

4 - 6 Months (Self Paced)
Maximum Allowed Duration: 18 Months
Expected Effort: 10-15 hours/week

Professional Diploma in Pharmacovigilance & Pharmacoepidemiology

This program provides training on pharmacovigilance systems, global safety standards, guidelines and regulations related to pharmacovigilance and also introduces you to some core concepts of pharmacoepidemiology.

TOTAL CREDITS: 18

Next Commencement Date

01 SEP

2019

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INTRODUCTION

Why study this program?


Introduction

Pharmacovigilance is a scientific discipline which is mainly concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of therapeutic drugs, devices or biologicals, thereby increasing their safety.

The clinical research regulatory agencies worldwide including US FDA, Indian DCGI and EMEA etc., are strengthening the safety laws for adoption of a systematic pharmacovigilance framework. The adverse event data generated by clinical trials world wide is enormous and has led to the outsourcing of the pharmacovigilance and pharmacoepidemilogy services of the pharma-biotech R&D. This fact compounded by the increasing number of local clinical trials has led to a spurt in the pharmacovigilance job market in India.

The Professional Diploma in pharmacovigilance and pharmacoepidemiology will provide a foundation in pharmacovigilance principles and operations. The curriculum is fully reviewed by industry professional and is relevant to aspirants who want to join the pharmacovigilance sector from both within and outside the pharmaceutical industry.

Each student will be assigned a mentor who will be a senior pharmacovigilance professional. Apart from providing practical knowledge of the subject it also helps students interface with the industry right from the day they join the course and design their career path.

PROGRAM STRUCTURE

What will be taught?


Program Structure

MODULE 1: GENERAL INTRODUCTION
MODULE 2: EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3: PRINCIPLES OF PHARMACOVIGILANCE
MODULE 4: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 5: PHARMACOVIGILANCE SYSTEMS
MODULE 6: GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 7: PHARMACOVIGILANCE REGULATIONS AND GUIDELINES
MODULE 8: PHARMACOEPIDEMIOLOGY

TOTAL CREDITS: 18

MODE OF STUDY: ONLINE

The curriculum for the program - Professional Diploma in Pharmacovigilance & Pharmacoepidemiology (PDPP) is extensive, has been developed and evaluated by experienced industry professionals and is fully endorsed by the industry. The program is suitable for fresh graduates as well as working professionals who either wish to grow further in their pharmacovigilance career, or those who wish to shift to the pharmacovigilance sector from any other related industry.

ASSESSMENT

How will I be assessed?


Assessment

Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.


Overall academic performance in the program is measured on a 4 point Cumulative Grade Point Average (CGPA) scale. More information about this is available here: Evaluation System

ELIGIBILITY

Am I eligible?


Eligibility

The minimum eligibility criteria for the Professional Diploma in Pharmacovigilance and Pharmacoepidemiology (PDPP) would include either of the following:

- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health.
- Students in their final year of graduation for the above courses are also eligible to apply.

If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.

ACADEMIC SUPPORT

What support will I receive?


Academic Support

Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.


Each student enrolled in the Professional Diploma in Pharmacovigilance & Pharmacoepidemiology Course (PDPP) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.

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Program Fee

How much will it cost?
Please use our online fee calculator to calculate the fee applicable to you.



CAREER OPPORTUNITIES

This combination program of Pharmacovigilance & Pharmacoepidemiology is a unique program that opens up a number of career opportunities in the area of drug safety. Positions that can be explored with various pharmaceutical companies, CRO's, pharmacovigilance companies include Drug Safety Associate, Drug Safety Executive, Drug Safety Physician, Drug Safety Scientist etc.


EXPERT OPINION

A study report published by Frost & Sullivan, "World Pharmacovigilance Markets in Life Sciences," states that the pharmacovigilance market was worth US$1859.9 million in the year 2008 and is estimated to be US$2252.2 million by 2015.


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