6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
This program provides you with a thorough understanding of the core concepts of drug safety such as signal detection, post marketing surveillance, adverse event reporting and also introduces you to clinical research quality assurance.
TOTAL CREDITS: 32
Next Start Date
Why study this program?
Every now and then we come across news of drugs that are taken off the market due to new safety concerns coming to light. Say thanks to pharmacovigilance, the science of identifying, assessing, managing and reporting of adverse effects of drugs which helps maintain the quality of medical products available in the market. Pharmacovigilance, sometimes also referred to as drug safety plays a key role in assessing the safety of new drugs during the clinical development process and also of drugs that have been approved by regulatory agencies for marketing. Most pharmaceutical companies either have dedicated pharmacovigilance departments comprising of qualified and trained individuals who manage the organization's pharmacovigilance processes or they outsource the pharmacovigilance work to other companies specializing in providing pharmacovigilance services, contract research companies or similar vendors. This helps them focus on their new product development, sales and marketing while still maintaining compliance requirements by outsourcing drug safety to specialist companies. Whatever the case is pharmacovigilance professionals play a crucial role in ensuring that only safe products make it to the market and continue to stay. Due to increasing compliance requirements and strengthening of drug safety regulations in most countries pharmacovigilance professionals are now in more demand than ever before and this trend is expected to continue as companies are investing heavily in research and development efforts.
Clinical Quality Assurance is another area which has lately been in demand. All company's want to provide their clients with the highest quality work which is in compliance with all applicable guidelines and regulations. Any error or oversight has the potential to cause a big dent in a company's reputation. Thus, Clinical Quality Assurance departments exist in all companies that provide clinical research services or conduct any sort of clinical research work. Professionals working in this department ensure that standard operating procedures and policies are developed and followed that incorporate all the compliance requirements. They train the company's workforce on various procedures and conduct routine audits to ensure that the processes set forth by the management are being followed. Any issues that are identified are resolved and corrective and preventive actions are put in place.
This pharmacovigilance and quality assurance program is very unique as it marries these two different lines of work, finds synergies in between and allows you to explore both these exciting career options. In this program you will learn all the core concepts of drug safety and quality assurance taking your skills and knowledge to the level expected of a pharmacovigilance and quality assurance professional.
What will be taught?
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: QUALITY & QUALITY MANAGEMENT
MODULE 10: THE QUALITY ASSURANCE FUNCTION
MODULE 11: AUDITS
MODULE 12: QUALITY GUIDELINES
MODULE 13: GCP/GMP/GLP
TOTAL CREDITS: 32
MODE OF STUDY: ONLINE
The curriculum for the program - The Advanced Post Graduate Diploma in Pharmacovigilance & Quality Assurance (APGDP-QA) is extensive, has been developed and evaluated by experienced pharmacovigilance and quality assurance professionals and is fully endorsed by the industry. Not only is this program suitable for new graduates but also for working professionals who either wish to grow further in their pharmacovigilance or quality assurance career, or those who wish to make a move to these sectors from any other related industry.
How will I be assessed?
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.
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
Am I eligible?
The minimum eligibility criteria for Advanced Post-Graduate Diploma in Pharmacovigilance & Quality Assurance (APGDP-QA) 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 clinical research / pharmacovigilance / quality assurance / allied areas. Please contact our admission representatives / counsellor to discuss your case.
What support will I receive?
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 & Quality Assurance 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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James Lind Institute offers various masters degree programs in the areas of public health, business administration etc.
- MPH (with specializations)
- M.Sc in Health Mgmt
- MBA (various specializations)
For information on available masters programs via our School of Health Sciences; & our Business School click below:
This is a perfect program those who are inclined towards both drug safety as well as clinical quality assurance. This unique program allows students to study both these areas in detail and explore career opportunities related to both. Participants can find opportunities with pharmaceutical companies, CRO's, pharmacovigilance companies, consulting agencies, auditing firms and many similar organizations. Positions related to pharmacovigilance that can be explored include Drug Safety Associate, Drug Safety Coordinator, Drug Safety Scientist, Case Processing Expert etc. Positions related to QA are Quality Assurance Executive, Quality Assurance Associate, Quality Assurance Manager among many others..
Both pharmacovigilance and quality assurance offer excellent career growth. With a few years of work experience people who perform well can move to managerial and senior managerial roles such as Team Leader or Head of Department. People with good people management skills can also move to senior management to roles such as Director and Senior Director.