Advanced Certified Program in Pharmacovigilance

With the globalization of the pharmaceutical industry, increased use of medicines and public awareness of safety issues have come forth. India is the fourth largest producer of pharmaceuticals in the world and there is a surfeit of drug brands-more than 6,000 licensed drug manufacturers and over 60,000 branded formulations emerging as a preferred hub for clinical trials and to carry out post marketing surveillance i.e. of the approved drugs. Pharmacovigilance is particularly important in the first few years after launch, when knowledge of the safety profile is based on exposure to a much wider range of patients than is possible during clinical trials.

Pharmacovigilance in India is gaining momentum within the arena of Research and Development. As Pharmacovigilance is becoming an important part of drug development as it deals with the patients’ safety. Keeping this in mind, Gratisol Labs has designed a proficiency program on Pharmacovigilance.

"This program will increase the knowledge and importance of quality assurance amongst clinical research professional, which eventually would help in increasing the quality of clinical trials in India".

 Course Objectives:
The course will help participants acquire a basic understanding of the concepts and practice of pharmacovigilance. The course would sensitize the students and equips them with knowledge on Pharmacovigilance practices worldwide and on the Indian scenario in detail. The objectives of the course are as follows:

• To enable participants to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs).
• The manner in which ADRs are detected and monitored, and the related historic and legal frameworks.
• To introduce participants to fundamental statistical, compliance and regulations concepts and methods.

 Career Opportunities

The potential opportunities and the growth prospects in the field of Pharmacovigilance are huge. The principal role of a Pharmacovigilance officer starts right from the start of preclinical studies and continues even after post marketing of the drug as drugs are evaluated for toxicity in a limited group of patients before marketing. He would be responsible for the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem both long term and short term side-effects of medicines; thereby improving the safety of drugs.

After the completion of the program the students would be eligible for the following types of jobs:

• Drug Safety Associate
• Safety Data Analyst
• Clinical Safety Scientist 
• Drug Safety Physician role for Doctors
• Clinical Pharmacovigilance Officer
• Clinical Pharmacovigilance Associate
• Pharmacovigilance Manager