6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
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
Why study this program?
Pharmacovigilance is an exciting discipline that pertains to the safety of drugs available in the market as well as those that are still in the development phase i.e. undergoing clinical trials. Post-marketing surveillance is the term used for monitoring the safety of an already marketed drug or a therapeutic device. To identify side effects of drugs it is of prime importance to keep collecting safety data from a large set of population. A Pharmacovigilance centre or department, takes the lead in monitoring the side effects of drugs as marketed drugs may possess risks that have not been fully identified & assessed during clinical trials. Working in pharmacovigilance requires knowledge of principles of pharmacovigilance, pharmacovigilance safety standards, its regulations & guidelines, pharmacovigilance systems etc. The pharmacovigilance team invokes greater responsibilities for a drug safety mechanism to prevent/ treat the adverse side effects caused by a drug or device depending on its drug-dose & intake.
Medical writing is very different from creative writing as it involves writing of regulatory, marketing or other scientific documents. An individual who works on these specialized aspects of writing is positioned to be a Medical Writer. These medical writers are not scientists who carry out research, or doctors who practice medicine, but are core professional writers who possess excellent knowledge of all regulatory aspects, especially of the pharmaceutical regulatory domain. Medical writers primarily work on new drug applications, case study reports, intellectual property rights writing, evidence based medicine, clinical trial protocols and several other documents. A medical writer teams up with scientists, doctors, and other subject-specialists in providing evidence and matter, that efficiently exemplify research outcomes used for regulatory submissions, demonstrating the effectiveness of a product & communicating its therapeutic information for marketing. A medical writer needs to precisely fulfill the requirements of the applicable regulatory authorities or the targeted journal as far as the format, content and writing styles are concerned.
The combination of Pharmacovigilance & Medical Writing is a distinctive program that provides a number of career opportunities & challenges in the area of drug safety as well as medical / scientific writing. In addition to training the participants on how to write regulatory documents, it also enhances their knowledge on to how to deal with pre and post marketing clinical safety and pharmacovigilance, risk management strategies, how to plan for a safety inspection, approach in diagnosis and management of adverse drug reactions, and drug safety surveillance and epidemiology.
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: 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
How will I be assessed?
Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.
Am I eligible?
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.
What support will I receive?
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 Advanced Post-Graduate Diploma in Pharmacovigilance & Medical Writing Course (APGDPV-MW) 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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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.
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.