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 Pharmacovigilance officer.
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 pharmacovigilance. 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 Pharmacovigilance and Data Management is bright for the sincere and diligent student and the working professional. Career opportunities in Pharmacovigilance includes:
- Clinical Pharmacovigilance Officer.
- Clinical Pharmacovigilance 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.
The main objective of this course is to develop experts/skilled professionals to handle large clinical data with correct spatial orientation of clinical research data management. The course will help participants to acquire a basic understanding of the concepts and practices of pharmacovigilance. 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 pharmacovigilance /clinical data management domain. The regulatory perspectives of clinical trials & Pharmacovigilance are the important part of the course.
The course has been framed with the following objectives:
- 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 pharmacovigilance and medical affairs team function and their dependency on data management.
Any Science Graduate
Every student has to pay Rs.500/- per module as examination fees. Examination fee for overseas participants is USD 30 Per Module