Clinical Trials Data Management and Pharmaco-vigilance

Overview

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 : Clinical Trials, Biostatistics and Reporting Analysis

Module II : Clinical Trials Data Management

Module III : Pharmaco-vigilance, Risk Management, Regulations and Compliance to

Clinical Safety

Module IV : Adverse Drug Reactions Reporting and Signal Detection Systems

Module V : ICH-GCP Guidelines for Clinical Trials

Module VI : Contract Research

Module VII : Assurance and Control of Pharmaceutics

Module VIII :Documentation and Medical Writing

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.

For further details and enquiries

Call:0120-4320801/02

Mob:09810535368,9818473366

E-mail : info@bii.in

BIOINFORMATICS INSTITUTE OF INDIA

H-109, Ground Floor Sector-63

Noida - 201 307 (U.P) (INDIA)

Call : 0120-4320801/02

Mobile : 09818473366,09810535368

E-mail : info@bii.in

Website: www.bii.in