Clinical Research and Pharmacovigilance

Clinical Research and Pharmacovigilance Syllabus

CLINICAL RESEARCH & PHARMACOVIGILANCE

Global Institute of Health Science is a pioneer in health science education, especially in distance and online learning. The institute is ISO 21001:2018 certified and globally acclaimed, with copyright approval from IPR Government of India and international certification from UASL UK for Quality Control Management Systems.

The GIHS Advantage

Bringing Excellence to Health Professionals
15+ Years of Experience with International Exposure
Internationally Acclaimed with ISO & Government Approval
Lifetime Free Personalized Tutoring for Student Success

GIHS Clinical Research and Pharmacovigilance courses online program is designed to provide total overview and skill globally in the field of clinical research. It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management. It is designed to provide total overview and skill globally in the field of clinical research, and pharmacovigilance. It would help professionals to upgrade & develop their knowledge about clinical trials, data management, pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance. to understand the key concepts in the responsible conduct of research and that conforms to the highest standards for the protection of human research subjects. It can be able to critically appraise the medical scientific literature, including the methodology of published and proposed investigations.

Syllabus

Table of Content

Introduction of clinical research
Clinical Trial Phases / Pharmacological Principal of Clinical Research
Drug Development and Launch
Indian Regulation (domestic regulation)
ICH GCP / Schedule Y / ICMR / Indian GCP
Key Stakeholders in Clinical Research
Ethics Committees and Institutional Review Board
Responsibilities of Sponsor / Responsibilities of Investigator
Responsibilities of Sponsor – Investigator / Responsibilities of Sponsor – Vendor
Clinical Trial Design and Project Managements
Clinical Trial Design / Vendor Selection and Managements
Project Planning / Project Managements
Principles of good clinical practices
Protocol Design / CRF Design
Essential documents in clinical research and regulatory requirements
Essential Documents / IND Application
Clinical Study Report / NDA Application
Informed Consent Process and Documentation
Study setup process
Site Selection and Pre- Study Visits
Site Initiation / Subject Recruitment and Retention Planning
Site Contract and Budgeting
QC, Compliance & Auditing in Clinical Research
21 CRF Part 11 / Site Auditing
Sponsor Compliance and Auditing / SOP for Clinical Research
Clinical Monitoring
CRF Review & Source Data Verification
Drug Safety Reporting / Drug Accountability Work
Routine Site Monitoring / Site Close Out Visit
PHARMACOVIGILANCE
Introduction of Pharmacovigilance
Overview of Pharmacovigilance
Standard Terms and Terminology in Pharmacovigilance
Medical Evaluation of Adverse Events in Pharmacovigilance
Adverse Event Reporting System and Form / Diagnosis and Managements of ADRs / Medical Evaluation of AE
Case Processing
Global Perspective of Pharmacovigilance
Single Case Processing / Case Narrative Writing
Pharmacovigilance Reporting Database, Signal Detection, Managements and Risk Assessments & Evaluation
Quality System in PV / Expedited Reporting Criteria
PSUR & PBRER / PV Database and Signal Detection
Risk Assessments & Management
Medical Dictionary for Regulatory Activities medDRA
medDRA
PV laws and Guideline
Regulatory Guideline @ Laws in PV / SOPS in PV
PV Auditing And Inspection / Regulatory Aspects In PV

Download PDF

Clinical Research and Pharmacovigilance

GHIS Clinical Research and Pharmacovigilance courses online program is designed to provide total overview and skill globally in the field of clinical research. It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management. It is designed to provide total overview and skill globally in the field of clinical research, and pharmacovigilance. It would help professionals to upgrade & develop their knowledge about clinical trials, data management, pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance.

Course Objective

The program objective is to understand the key concepts in the responsible conduct of research and that conforms to the highest standards for the protection of human research subjects. It can be able to critically appraise the medical scientific literature, including the methodology of published and proposed investigations. It can be able to independently formulate a research question, as well as be able to design and conduct a study to address that question. It can be able to present and publish the results of one’s scholarly work. It is to identify a focus for future research and scholarly work, and to develop special expertise in the corresponding clinical domain and/or research methods. It would help you to gain in-depth knowledge on the best way to collect and report adverse events and safety data and manage the risk associated with and risk to your products. This advanced training pharmacovigilance short courses in India provide you with the unique format skills and knowledge that needed to operate a fast, effective drug safety or pharmacovigilance program. We provide best diploma, graduate and post graduate certificate courses to college students to enhance their start up in clinical research and pharmacovigilance.

Eligibility

Mode or Methodology

Certification

Examination

Placement Assurance

Career Options

Pharmacovigilance Associate

Drug safety specialist

Clinical Research Associate

Clinical Research Coordinator

Fees, Payment & Program Duration

Certificate Program

Foundation-level program
Core concept learning
Industry awareness focus
Expert-designed syllabus
Research-based curriculum
Academic & tech support
Skill development course
Govt-recognized program
Global accreditation & recognition
Globally ISO certified

*Fees subject to taxes & exchange rates.

Post Graduate Diploma Program

Advanced-level professional course
Comprehensive concept mastery
Research-based modules
Lifetime expert support
Job & career assistance
Free Career Boost (www.TopCVCoach.com)
High employment potential
Govt-recognized program
Global accreditation & recognition
Globally ISO certified

*Fees subject to taxes & exchange rates.

Fast Track PG Diploma Program

Accelerated PG-level program
Flexible learning format
Self-paced completion
Lifetime expert support
Research-driven curriculum
Free Career Boost (www.TopCVCoach.com)
Job-oriented training
Govt-recognized program
Global accreditation & recognition
Globally ISO certified

*Fees subject to taxes & exchange rates.

Join GIHS Programs now and unlock an exclusive FREE TopCV Coach access worth ₹9,999/-

Enroll today and receive complimentary access to TopCV Coach, giving you the professional resume and interview skills needed to confidently launch your career.

Sarah Lilly-MBA

08:37 10 Apr 26

From the day 1 to till date Chethan assisted very well and had a smooth journey till I had received my certificates through courier. And the studies are very detailed and made interesting. Thank you😊

Brandon SJ

09:55 04 Apr 26

I took an EEG course through GIHS that I really enjoyed. The course expanded my mind and pushed me in a lot of ways to capture complex nuances to the process and machinations of EEG and how it works giving me the confidence needed when as I embark on this field. In addition to the learning materials - the communication was exceptional from officials and anything that you needed help with they were there willing and ready able to assist. Thank you so much GIHS!

Kirti Saxena

09:02 19 Mar 26

"Great experience! The faculty is knowledgeable and approachable. The resources and facilities are top-notch. Would definitely recommend."

Andrea Del Pilar

13:31 18 Mar 26

They have a very good independent study methodology and the subject matter is really good; in my personal case, since this specialization is not available in my country, the Institute of Health was a wise choice.

Vinitha Siva

12:35 18 Mar 26

Assistance is good 24/7 , the content of the course can be improved slightly, other than that it was great . Thanks for the support

Samridhi Sharma

11:02 22 Dec 25

The PG Diploma in Nutrition course covers the basic concepts clearly. Teaching is satisfactory and the study material is useful for understanding nutrition fundamentals. Overall, it is a decent course for those looking to gain knowledge in this field.

A V

08:01 08 Oct 25

One of the best institutions. I have recently completed my PG Diploma in Clinical Research and Pharmacology. Course is carefully structured and detailed. Management is very well organised and prompt in assistance.

I would highly recommend this institution.

Akram Sabiq

17:49 05 Oct 25

"I'm impressed with the comprehensive coverage of international standards and laboratory skills, which were not adequately addressed in my previous academic programs. This course has been a game-changer for me, providing the knowledge and skills necessary to succeed as a lab technician on a global platform."

susigarans

10:53 29 Aug 25

My Experience with GIHSS and the PG Diploma in Health Informatics & Management

I am grateful for the opportunity to pursue the PG Diploma in Health Informatics & Management at GIHSS. Throughout the course, I learned a wealth of knowledge that has significantly enhanced my understanding of the healthcare industry and the role of technology in improving patient care.

The curriculum was comprehensive, covering essential topics such as health information systems, data management, healthcare analytics, and health policy. The faculty were highly experienced and supportive, always ready to clarify doubts and encourage practical learning. The program also emphasized real-world applications, which helped me develop critical skills needed in the healthcare sector.

Thanks to GIHSS, I now have a solid foundation in health informatics, enabling me to contribute effectively to healthcare organizations. Overall, this course has been a valuable stepping stone in my professional development, and I highly recommend it to anyone interested in bridging healthcare and technology.

Wishing everyone success in their learning journey! Best wishes to all future students.

Sincerely

Denis

Dr Fatema Ebrahim

10:43 25 Jul 25

I recently completed my Post Graduation in Pregnancy and Child Care from GIHS and it was a wonderful experience. The course was well-structured, and the faculty was supportive and knowledgeable. I gained in-depth knowledge about all the aspects of pregnancy and childcare, that have prepared me to confidently support mothers and babies. Highly recommended .

Frequently Asked Questions

What is clinical research and pharmacovigilance?

Clinical research involves conducting studies to evaluate the safety and efficacy of new medical treatments, drugs, or devices in human subjects. Pharmacovigilance, on the other hand, focuses on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

Is pharmacovigilance a good career?

Yes! With the increasing emphasis on drug safety and regulatory compliance, there is a growing demand for professionals in pharmacovigilance.

Who is eligible for a pharmacovigilance course?

Individuals with a background in life sciences, pharmacy, medicine, nursing, or related fields are eligible for pharmacovigilance courses.

Is pharmacovigilance better than medical coding?

Pharmacovigilance and medical coding are different fields with distinct roles. Pharmacovigilance focuses on drug safety and adverse event reporting, while medical coding involves assigning codes to medical diagnoses and procedures for billing and record-keeping. The choice depends on individual interests, skills, and career goals.

Is pharmacovigilance in demand?

Yes, due to increased regulatory scrutiny and the need for pharmaceutical companies to ensure the safety of their products, pharmacovigilance is in demand.

Other Related Courses

Clinical Research Courses

Clinical Research & Quality Assurance /GCP Audits & Inspections

Clinical Research Courses

Pharmacovigilance & Medical/Scientific Writings

Clinical Research Courses

Clinical Trial Management

Clinical Research Courses

Regulatory affairs IPR & Patents

Real Stories. Real Achievements

Discover how our students turned learning into lasting success across top industries worldwide.

Where Our Graduates Are Making an Impact

Why Choose GIHS?

At GIHS, we blend academic excellence with practical industry exposure, offering globally recognized health science programs designed to elevate your career in the fastest-growing healthcare sectors.

Bringing Excellence To Health Professionals

15+ Years Of Industry Experience

ISO & Government Certified Institute

Personalized Tutoring For Success

Request More Information

Want to know more about our programs or find the right course for you? Fill out the form below and our academic counsellors will connect with you shortly.

Request More Information

Enquire Today

Our experts will reach out within 24 hours to assist you.

Clinical Research and Pharmacovigilance

Clinical Research and Pharmacovigilance Syllabus

CLINICAL RESEARCH & PHARMACOVIGILANCE

The GIHS Advantage

Syllabus

Clinical Research and Pharmacovigilance

Course Objective

Eligibility

Mode or Methodology

Certification

Examination

Placement Assurance

Career Options

Pharmacovigilance Associate

Drug safety specialist

Clinical Research Associate

Clinical Research Coordinator

Fees, Payment & Program Duration

Certificate Program

Post Graduate Diploma Program

Fast Track PG Diploma Program

Join GIHS Programs now and unlock an exclusive FREE TopCV Coach access worth ₹9,999/-

Frequently Asked Questions

Yes! With the increasing emphasis on drug safety and regulatory compliance, there is a growing demand for professionals in pharmacovigilance.

Individuals with a background in life sciences, pharmacy, medicine, nursing, or related fields are eligible for pharmacovigilance courses.

Yes, due to increased regulatory scrutiny and the need for pharmaceutical companies to ensure the safety of their products, pharmacovigilance is in demand.

Other Related Courses

Clinical Research & Quality Assurance /GCP Audits & Inspections

Pharmacovigilance & Medical/Scientific Writings

Clinical Trial Management

Regulatory affairs IPR & Patents

Real Stories. Real Achievements

Where Our Graduates Are Making an Impact

Why Choose GIHS?

Bringing Excellence To Health Professionals

15+ Years Of Industry Experience

ISO & Government Certified Institute

Personalized Tutoring For Success

Request More Information

Request More Information

Enquire Today

Clinical Research and Pharmacovigilance

Clinical Research and Pharmacovigilance

Enter Details To Get Syllabus