Clinical Development Sciences

PROGRAM DURATION

6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week

Advanced PG Diploma in Pharmacovigilance & Medical Writing

This program provides you a thorough understanding of the core concepts of drug safety (pharmacovigilance) as well as helps you develop skills related to writing of various clinical trial documents such as study reports, scientific papers etc.

TOTAL CREDITS: 32

Next Commencement Date

15 DEC

2018

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INTRODUCTION

Why study this program?


Introduction

Pharmacovigilance involves many lead scientific activities that have increased in complexity due to coercion of potential markets & larger volumes of data. Pharmacovigilance depicts pharmacological science, which is also known as drug safety. It is to collect, discover, estimate, monitor and prevent adverse effects of those pharmaceutical drugs that are in the market and in development. It has its focus mainly on Adverse Drug Reactions (ADR’s), which may occur with various dose levels. Improper use of medication such as overdose / abuse, or misuse are also considered in reporting of adverse drug reactions. The objective of pharmacovigilance is to eventually identify the detrimental effects of drugs & to minimize the possible harm that can be caused to patients.

Medical writing is a professional field that carries forward a great demand and exposure in the industry. The field primarily involves writing documents related to the pharmaceutical industry however it also covers writing in a more general sense such as writing medical articles for journal publications, writing about health topics for various healthcare portals, academic writing etc. Its foremost requirement is communicating clinical / scientific data to an array of audiences abiding by the format issued by the regulatory authorities or the formats / guidelines issued by the publisher. Apart from contributing time & patience to research findings, a medical writer puts up a fusion of their knowledge in science / research & their communication skills to bring to the table a steady format of presentations of their work described earlier. A combination of these two areas i.e. pharmacovigilance and medical writing can reward interesting career prospects.

PROGRAM STRUCTURE

What will be taught?


Program Structure

MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 03: PRINCIPLES OF PHARMACOVIGILANCE
MODULE 04: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 05: PHARMACOVIGILANCE SYSTEMS
MODULE 06: GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 07: PHARMACOVIGILANCE REGULATIONS & GUIDELINES
MODULE 08: PHARMACOEPIDEMIOLOGY
MODULE 09: BASICS OF GOOD MEDICAL WRITING
MODULE 10: COMPUTER SKILLS
MODULE 11: OVERVIEW OF THE REGULATORY, MARKETING AND DRUG PROMOTION PROCESSES
MODULE 12: COMMON TECHNICAL DOCUMENT
MODULE 13: PROTOCOL, INVESTIGATOR’s BROCHURE & CASE REPORT FORMS
MODULE 14: CLINICAL STUDY REPORT
MODULE 15: SENTENCE CONTROL
MODULE 16: WRITING FLOW AND COHESIVENESS
MODULE 17: PUBLICATION WRITING
MODULE 18: DOCUMENTS IN MEDICO-MARKETING
MODULE 19: MANAGING THE REVIEW PROCESS

TOTAL CREDITS: 32

MODE OF STUDY: ONLINE

ASSESSMENT

How will I be assessed?


Assessment

You will be assessed on an ongoing basis by the faulty based on the following three criteria:
One is the completion of the online multiple choice question tests that follow each lesson; second is the timely submission of assignments and third is your level of participation in the instructor led online discussions within the JLI e-Campus.

Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System

ELIGIBILITY

Am I eligible?


Eligibility

The minimum eligibility criteria for Advanced Post-Graduate Diploma in Pharmacovigilance and Medical Writing (APGDP-MW) 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.

Candidates without any science background or candidates with some work experience in the clinical research / pharmaceutical industry / allied areas may also be eligible for this program. Please check with our counsellors for more information.

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 Advanced Post-Graduate Diploma in Pharmacovigilance & Medical Writing course is provided with a mentor who is an experienced industry professional. 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

Pharmacovigilance professionals can work in pharmacovigilance departments as a Drug Safety Associate, Drug Safety Executive, Drug Safety Coordinator, Drug Safety Scientist etc. In Medical Writing departments positions that can be explored include Medical Writer, Sr. Medical Writer, Medical Writer Team Lead etc.


EXPERT OPINION

Both Drug Safety and Medical Writing are vital departments within a company. The former make sure that only safe drugs stay in the market while the later make sure that scientific information is communicated to each audience in an appropriate language.


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