Chitkara University announced the launch of a 2-year M.Sc Program in Pharmacovigilance & Clinical research, in collaboration with Parexel, a leading provider of solutions to accelerate the development and delivery of innovative new therapies to improve world health, from Clinical through Commercialization, The program is aimed at addressing the concern of talent crunch in the pharmacovigilance industry and contribute towards building the research and development capacity of India.
The 2-year master’s degree program in Pharmacovigilance & Clinical research is designed to create skilled and competent professionals who can work effectively at different levels in Pharmacovigilance departments of leading Pharma companies and Clinical Research Organizations (CROs) in India as well as around the world. Parexel, a leading CRO, will provide industry and curriculum support from its Parexel Academy as a part of the collaboration.
Commenting on the collaboration, Sanjay Vyas, Senior Vice President, India Country Head & Head CTS&L, Parexel International, said, “We have always had a strong focus in growing India as a ClinicalOperational Hub supporting both our local and global drug development. The Clinical research industry has seen a tremendous boost in recent years and this growth requires strong skill sets and talent to help bring new therapies to market. To develop this talent requires combined practical and academic experience. With this partnership with Chitkara University Parexel hopes to help develop the future workforce of the clinical research industry, that will be instrumental in shaping the future of R&D in India and supporting the needs of patients.”
Dr. Madhu Chitkara, Pro-Chancellor of Chitkara University, said, “The 2-year M.Sc. Program in Pharmacovigilance & Clinical research, offered in collaboration with Parexel, is an outcome of Chitkara University’s relentless focus on offering programs designed and delivered in conjunction with the industry leaders and contribute to nation-building by developing indigenous talent. Chitkara University affirms its support to the Prime Minister’s mission of ‘Atmanirbhar Bharat.’ This collaboration will ensure that the curriculum is dynamic and tailored to the constantly evolving industry trends. Students get exposure to the industry’s best practices during their degree.”
Program and curriculum
The industry-led curriculum includes an in-depth study of pharmacovigilance related processes, complemented with hands-on training on advanced ICSR processing, quality management, pharmacovigilance medical safety writing, aggregate report (PSUR/PBRER/ PADER, etc.) writing and compliance management. The program will expose students to the internationally compliant pharmacovigilance training based on defined Pharmacovigilance Competency Frameworks (PCF) and help develop internationally accepted competencies, under the mentorship of industry leaders.
Continuous and timely interaction with industries including leading Pharmaceutical companies and CROs (nationally and internationally), and government organizations for academics, conferences, and placements are an integral part of this program. The second-year has been designed to include specialization centric studies and internship opportunities in industry settings, either in association with a clinical research organization or a Pharmaceutical company.
The students graduating from this program can find employment as Pharmacovigilance Scientists, Pharmacovigilance Quality Reviewers, Pharmacovigilance Quality Analysts, Pharmacovigilance Medical Safety Writers, Pharmacovigilance System Specialists, etc.
The past two decades have witnessed an unprecedented increase in the prevalence of chronic diseases such as oncological diseases, diabetes, and cardiovascular, respiratory, and lifestyle disorders have led to a rise in drug consumption worldwide. With increasing patient count, the incidents of Adverse Drug Reactions (ADRs) are expected to accelerate the demand for Pharmacovigilance services, which is now an inevitable part of drug discovery and development procedures. The global pharmacovigilance market size was estimated at USD 4.87 billion in 2019 and is expected to witness a CAGR of 13.2% over the next ten years.