Introduction to Pharmacovigilance

Without Pharmacovigilance, clinical research cannot be accomplished since drug safety monitoring is the foundation for keeping a society safe and healthy. Pharmacovigilance is a scientific discipline that focuses on detecting, validating, quantifying, assessing, and improving drug safety. The key activities in Pharmacovigilance include delivering end-to-end medical, safety, and analytical services such as medical review, causality assessment, case narratives and processing, and adverse drug reaction prevention with the involvement of regulatory authority. The Pharmacovigilance course covers all of these topics, with an emphasis on reporting systems and various ADR forms, causality assessment, case narration, risk management plans, and various pharmacovigilance programs. This course will provide you a solid understanding of the pharmacovigilance process and operations. Our curriculum is completely industry‑specific and appropriate to applicants from both within and outside the pharmaceutical industry who want to be a part of the pharmacovigilance sector.

Course Description

Clinical Research activity will not be completed without pharmacovigilance because drug safety monitoring is the basis for keeping a society safe and healthy. Pharmacovigilance is a scientific discipline which is mainly concerned with identifying, validating, quantifying, evaluating and increasing the drug safety. The main activities in Pharmacovigilance involve providing end to end medical, safety and analytical services which include medical review, causality assessment, case narratives and processing, and prevention of adverse reactions with the involvement of regulatory authority. The Pharmacovigilance course covers all these areas focussing on the reporting systems and the different ADR forms, causality assessment, case narration, risk management plan and various pharmacovigilance programmes. This course will provide a foundation in the pharmacovigilance process and operations. Our curriculum is fully industry specific and is relevant to aspirants who want to join the pharmacovigilance sector from both within and outside the pharmaceutical industry.

Who should apply?

  • MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS
  • Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences
  • Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology)
  • Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics
  • Graduate or equivalent degree in Nursing/Allied Health
  • Students in their final year of graduation for the above courses can also apply

What you will learn in this course

This pharmacovigilance certificate course will help the life science and health science graduates to learn about the overview of PV, learn about AE, ADR reporting, Yellow Card and Medwatch, understand casualty assessment and delve into the practice of narrative writing.

Structure of Course Delivery

The entire Pharmacovigilance course will be made available online. It consists of several in-depth lectures delivered by a subject matter expert, appropriately supported by slides, images, and interactive materials where necessary. The delivery has a tremendous degree of versatility. A class may be paused to allow you to take notes and refer to your textbooks (not provided). If you already know a certain part of the lecture, you can rewind it to hear it again or skip a slide or two. You are free to go back over a section at a later time if you need to review it before your assessment. You are free to take the topics in this online pharmacovigilance course in whatever order you choose, even though our curriculum may prescribe otherwise.

Benefits

Many of our students felt that the way this pharmacovigilance course taught has made it easier for them to keep up with the intense lectures in real class— it's like having a TV remote in class to self-pace your teacher.

Visuals in the presentations aid in better comprehension by making topics easier to learn... and more difficult to forget!

Chapters

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Dr Divya Sunil
Academic Mentor

Dr. Divya Sunil has graduated with a degree in Dentistry from Bangalore University and a PG Diploma in Clinical Research. She is passionately involved in training and motivating students who are new to the world of clinical research.

Dr. Divya is proficient in Pre-Clinical Studies, laws governing the production of drugs, designing the database for Clinical studies, medical coding, and guidelines for post-marketing surveillance.

Previously, Dr. Divya has worked as an academic mentor at a private dental college in Bangalore where she has taught more than 10,000 students. She has also co-authored an article in the monthly journal,” TRENDS IN PROSTHODONTICS” VOL 4, NO. 1 (2013) on Bone Implant contact and its relationship with the strain on the surrounding bone.

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Ms Amrutha Babu
Academic Mentor

Ms. Amrutha is an accomplished academic expert in the field of Food and Nutrition. She has a Master’s degree from Mahatma Gandhi University, Kottayam where she graduated with a gold medal. After undergoing training in Christian Medical College, Vellore started her career as a freelance diet counselor in 2009. She was also associated with Lybrate - an online platform for diet management and counseling.

After a remarkable experience in the field of dietetics, she received a post-graduate diploma in Clinical Research. Currently, she is associated with TrueLessons as an academic mentor. Her core strengths are providing excellent teaching and guidance to her students. Amrutha has more than 7 years of teaching experience in the field of clinical research. She has in-depth knowledge about Drug Discovery Process, Drug Approval process, Trial documents, Trial Design, Regulatory Affairs, Query writing, ICSR, and so on.

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Dr. Smitha Seshagiri
Academic Mentor

Dr. Smitha Seshagiri has completed her PGDCR from Avigna Clinical Research Institute. She has an experience of 4+ years. She is also a practicing dentist and a wellness coach.

This program will provide the students with an opportunity to work with various MNCs.

Students can get engaged in different profiles like

  • Drug Safety Associate
  • Drug Safety Physician
  • Medical Reviewer
  • Medical Coder
  • Quality Analyst
  • Narrative Writer
₹34999

₹29999

  • Duration 12 hours
  • Chapters 12
  • Skill Level Beginner
  • Language English
  • Instructor Dr Divya Sunil
  • Instructor Ms Amrutha Babu
  • Instructor Dr Smitha Seshagiri
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