Post Graduate Diploma in Pharmacovigilance & Clinical Data Management, PGDPVCDM
Pharmacovigilance (Drug safety) is a crucial aspect in the development of new drugs as well as the continued marketing of drugs available in the market. Pharmaceutical companies are required by law to ensure that the drugs that they develop are safe for the population and thus many steps are undertaken throughout the life cycle of a drug to ensure that safety data is collected, analysed and reported appropriately. The area of drug safety is coming up in a big way in developing countries while opportunities are also growing in developed countries.
Clinical Data Management on the other hand plays a very important role in managing the huge amount of data that is obtained during clinical trials. Data management professionals ensure that the data is managed by means of specialized software's. so that the data is error free, accurate and ready for analysis by biostatisticians. Data management staff also develop the data management plan before data collection begins and develop various tools used by the research staff for collecting data. The data management staff works closely with the clinical operations department, medical writers, biostatisticians, regulatory affairs teams and many other functional teams. People trained in data management can explore careers in contract research organizations, pharmaceutical companies, pharma IT companies etc.
Pharmacovigilance, in layman’s terms is drug safety. It can be defined as the study and prevention of adverse effects caused by pharmaceutical products. Pharmacovigilance is the reason that many drugs are withdrawn from or not even brought into the market at times. All this has led to explosive demand for trained and skilled personnel in this field. This program aims to train professionals in pharmacovigilance and clinical data management how can work as Research Coordinator, Research Associate, Drug Safety Associate, Senior Pharmacovigilance Consultants, Principal Investigator, Regulatory Consultant, Drug Safety Managers and Clinical Data Manager etc.
Any Medical Graduate