Chitkara University was the first university in the region to offer a postgraduate pharmacovigilance program in partnership with a leading clinical research organization (CRO).
Chandigarh: Chitkara University announced the launch of a two-year M.Sc program in pharmacovigilance and clinical research in partnership with Parexel, a leading provider of solutions to accelerate the development and delivery of innovative new therapies to improve world health from clinical to commercial The program aims Aims to address the pharmacovigilance industry talent crisis problem and help build India’s research and development capacity.
The two-year Masters in Pharmacovigilance and Clinical Research is designed to create skilled and competent professionals who can work effectively at various levels in pharmacovigilance departments of leading pharmaceutical companies and clinical research organizations (CROs) in India as well as around the world. Parexel, a leading CRO, will provide industry and curriculum support as part of the collaboration from its Parexel Academy.
Comment on cooperation, Sanjay Vyas, Senior Vice President, India Country Head & Head CTS & L, Parexel International, said: “We have always focused heavily on growing India as a ClinicalOperational Hub to support both our local and global drug development. The clinical research industry has seen a tremendous surge in recent years, and that growth requires strong skills and talent to help bring new therapies to market. Developing this talent requires a combination of practical and academic experience. With this partnership with Chitkara University, Parexel aims to help develop the future clinical research workforce who will be instrumental in shaping the future of research and development in India and supporting patient needs. “
Dr. Madhu Chitkara, Pro-Chancellor of Chitkara University, said, “The two-year M.Sc. program in pharmacovigilance and clinical research offered in partnership with Parexel is the result of Chitkara University’s relentless focus on offering programs that are developed and developed in collaboration with industry leaders Building through Indigenous Talent Development. Chitkara University reaffirms its support for the Prime Minister’s mission “Atmanirbhar Bharat”. This collaboration will ensure that the curriculum is dynamic and responsive to ever evolving industry trends The students gain insight into best practices in the industry during their studies. “
Program and curriculum
The industry-leading curriculum includes an in-depth study of the processes related to pharmacovigilance, complemented by hands-on training on advanced ICSR processing, quality management, medical safety writing in pharmacovigilance, overall reporting (PSUR / PBRER / PADER etc) and compliance management . The program will familiarize students with internationally compliant pharmacovigilance training based on defined pharmacovigilance competence frameworks (PCF) and help develop internationally recognized competencies under the guidance of industry leaders.
Continuous and timely interaction with industries such as leading pharmaceutical companies and CROs (national and international) as well as government organizations for academics, conferences and internships is an integral part of this program. The second year includes specialization-oriented studies and internship opportunities in industry settings, either in collaboration with a clinical research organization or a pharmaceutical company.
Students who complete this program can find employment as pharmacovigilance scientists, pharmacovigilance quality auditors, pharmacovigilance quality analysts, pharmacovigilance medical safety writers, pharmacovigilance systems specialists, etc.
Over the past two decades, the prevalence of chronic diseases such as oncological diseases, diabetes, and cardiovascular, respiratory and lifestyle disorders has increased unprecedented. As patient numbers have increased, the incidence of undesirable drugs has increased. Reactions (ADRs) are expected to accelerate the demand for pharmacovigilance services, which are an inevitable part of drug discovery and development processes today. The global pharmacovigilance market size was estimated at $ 4.87 billion in 2019 and is expected to grow at an annual rate of 13.2% over the next decade.