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Program Introduction
With the globalization of the pharmaceutical industry, increased use of medicines and public awareness of safety issues have come forth with the challenges in four areas of operations—organizational alignment, research & development , clinical trials data management, and risk & safety management. Thus in today’s biopharmaceutical product landscape, companies must be aware of crucial safety information about their products for which industry requires expertise and trained professionals in the domain related to clinical data management and safety monitoring department i.e. job profile like clinical data manager or Pharmaco-vigilance officer.
BII to endow the knowledge in the area of clinical trials and Pharmaco-vigilance has introduced the “Industry Program in Clinical Trials Data Management and Pharmaco-vigilance”.
Course Aims and Objectives:
The main objective of this course is to develop experts/skilled professionals to perform clinical data management tasks by having a correct spatial orientation of clinical research data management. The course will help participants to acquire a basic understanding of the concepts and practice of pharmaco-vigilance.
The objectives of the course is to enable participants to understand issues surrounding the risks and benefits of drug used in humans including the cause, manifestations and consequences of adverse drug effects (ADEs).The aim of the course is to have thorough insight on project management related to pharmaco-vigilance /clinical data management domain .The regulatory perspectives of clinical trials & Pharmaco-vigilance are the important part of the course.
Course-Curriculum :
Benefits of the course :
After the successful completion of this program, Students would be able to:
- Understand the regulatory perspectives on clinical research activities.
- Understand the protocol/study design and the database set-up.
- Perform database/procedure testing, data validation, SAE reconciliation and medical coding.
- Have a thorough insight on project management in data management domain.
- Understand how a pharmaco-vigilance and medical affairs team function and their dependency on data management.
Career Opportunities :
The course caters to industry demands and moulds both fresher as well as experienced candidates to become exceptional professionals in the arena of clinical research and pharmaco-vigilance. The course also dwells on modulating invisible resources (communication-oral and written, decision-making, leadership qualities and time management skills) that would enable the participants to stand in a better stead than other candidates in the fiercely competitive job market.
"Clinical data management" is a profession with increasing importance in product research and development process and is considered as an integral part of clinical trials. A career in both Pharmaco-vigilance and Data Management is bright for the sincere and diligent student and the working professional. Career opportunities in Pharmaco-vigilance includes as a
Clinical Pharmaco-vigilance Officer.
Clinical Pharmaco-vigilance Associate.
Regulatory Affairs Associate.
Clinical Drug Safety Associate and Clinical CRF Designer among others. For Data Management students, careers will be as Data Entry Operator, Research associates.
Data coordinators and statisticians.
Database Programmer.
Database designer.
Clinical data monitor.
QA/QC executive.
Project Manager.
BII Blog is available on
website. The link is http://www.biinoida.blogspot.com. All program participants are provided access to BII Blog.Eligibility.
The eligibilty for the training program is graduation in any discipline.Highly interested participants in final year can also apply.
Program Fee
BII Program Participation Fee for this program is Rs 17, 500/ (for participants based in India / USD 1200 ( for overseas participants ). Payment is to be made through Demand Draft / Telegraphic Transfer in favor of Bioinformatics Institute of India.
Course fees can be paid into two installment i.e. each installment of Rs. 9000.00 /- .
Examination Fees
Every student has to pay Rs.300/- per module as examination fees . Examination fee for overseas participants is USD 25 Per Module
Program Duration
The program duration is 12 months .
| Company Name |
Company Name |
| Panacea Biotech Ltd |
Elder Pharma Ltd |
| Glaxosmithkline |
Lupin Ltd. |
| A.I.I.M.S. |
Bio-Rad Laboratories (I) Pvt. Ltd. |
| Ranbaxy Lab Ltd. |
Aurobindo Pharma Ltd. |
| Cadila Pharmaceuticals Ltd. |
Pfizer Ltd |
| GSK India |
Shasun Chemicals&Drugs Ltd. |
| L&T Information Tech. Ltd. |
Polaris Software Lab Ltd. |
| Wipro Technologies |
Infosys Technologies Ltd. |
| ANR Right Gen Technology |
Deptt. Of Plant Molecular Biology Univ. Of Delhi |
| Merck India |
Charak Pharmaceuticals |
| CRRI |
UTI Bank Ltd. |
| GVM College of Pharmacy |
Harihar Fertilizers |
| Rexin pharmaceutical |
Uttaranchal Institute of Technology |
| Crompton Greaves Ltd. |
Sesa Goa Ltd. |
| DAV College |
BBMB Hospital Chandigarh |
| UV Vitamins |
Dr. Reddy's Lab |
| Stride Arcolab Ltd |
MSPL Ltd. |
| Vaidik Remedies, Nagpur |
Cosme Pharma |
| Reliance Life Sciences |
Clonegen Biotech |
| Baxter India Pvt Ltd |
Sun Pharma |
| Innovex |
Jubliant Organosys |
| Trabsegene Biotech Ltd |
Cipla Ltd. |
For further details and enquiries
Bioinformatics Institute of India
C-56 A/28, Sector - 62
Noida - 201301, UP(INDIA)
Tel : 0120 - 4320801/02
Mob : 09810535368
E-mail : info@bii.in
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