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 Start Date

01 JAN

2019

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INTRODUCTION

Why study this program?


Introduction

Pharmacovigilance is a branch of medical science / pharmacology which primarily deals with identifying, validating, quantifying, evaluating and minimizing the adverse effects of therapeutic drugs, medical devices or biologicals, thereby improving their safety.

Pharmaceutical drug regulatory authorities globally such as the US FDA, EMA, MHRA, DCGI etc., have brought in strong safety laws for the adoption of an organized pharmacovigilance network. The amount of drug side-effect data generated by clinical studies around the world is massive and this has led to the outsourcing of the pharmacovigilance and pharmacoepidemiology services by large multinational drug development companies. An increase in the number of clinical trials being conducted by local players in the pharmaceutical industry has also strengthened the pharmacovigilance and pharmacoeconomics job market globally.

This online training in pharmacovigilance and pharmacoepidemiology provides you with a groundwork in pharmacovigilance principles and operations. The program also provides training on pharmacovigilance systems, global safety standards, guidelines and regulations related to pharmacovigilance. The program curriculum is fully reviewed by pharmacovigilance experts and is appropriate for candidates who wish to enter the pharmacovigilance sector from both within and outside the pharmaceutical industry.

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

You will be assessed on an ongoing basis by the faculty based on the following criteria:

One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.

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

As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Professional Diploma in Pharmacovigilance & Pharmacoepidemiology Course is provided with a mentor who is an experienced professional from the industry. The mentor can be contacted at any time via email or phone.

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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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