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Clinical Trials Data Management and Pharmaco-vigilance (12 Months)


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”.

Aims & 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 :

  • Module I : Pharmacovigilance, Risk Management & Compliance to Clinical Safety
  • Module II : Pharmacovigilance Regulation to Clinical Safety
  • Module III : Adverse Drug Reactions, Reporting & Signal Detection System
  • Module IV : Bio-statistical Analysis of Clinical Trials Data
  • Module V : Clinical Trials & Regulation Analysis
  • Module VI : Clinical Trials Data Management
  • Module VII : ICH-GCP Guidelines for Clinical Trials
  • Module VIII :Contract Research
  • Module IX :Assurance & Control of Pharmaceutics
  • Module X :Medical Writing & Documentation
  • Research Study

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.

Eligibility : Any Science Graduate

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.

Program Fee

BII Program Participation Fee for this program is Rs 17, 700/ (for participants based in India / USD 1200 ( for overseas participants ). Payment is to be made through Demand Draft / At Par Cheque in favor of Bioinformatics Institute of India.

Course fees can be paid into two installment i.e. each installment of Rs. 9000 /- .

Examination Fees

Every student has to pay Rs.500/- per module as examination fees . Examination fee for overseas participants is USD 30 Per Module
Download the Examination Form

For further details and enquiries
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Global Students for any queries

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Download Application Form for Clinical Trials Data Management and Pharmaco-vigilance

Sms Bii to 56070
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