B.Sc.in Paramedical Technology (Clinical Research Data Management & Pharmacovigilance)

B.Sc. CRDMPV programme caters to evolving clinical research industry demands and enables candidates to become exceptional clinical research professionals.

Graduates of this programme may secure lucrative jobs in reputed healthcare organizations as Clinical Research Associate, Clinical Research Investigator, Clinical Research Coordinator, Data Manager / Biostatistician, Regulatory Affairs Manager, Clinical Trials Auditor, Clinical Project Manager, Clinical Research Manager, Business Development Manager, and Drug Safety Associate.

• The graduates will be skilled to have sufficient knowledge and skills in the field of clinical trials and research related to drugs and medicines (pharmaceuticals, nutraceuticals, cosmeceuticals, phytomedicine, herbal therapies and alternative systems of medicine).
• The graduates will be skilled to have sufficient knowledge and skills in the clinical trial data management and biostatistics.
• The graduates will be skilled to have sufficient knowledge and skills in the drug safety reporting (Pharmacovigilance).
• The graduates will develop skills to conduct and manage clinical trials at different types of clinical trial settings (single-centre, multi-centre and overseas sites).
• The graduates shall be able to develop understanding in the basic healthcare subjects and understand the terminologies used in healthcare practice.
• The graduates will develop skills and knowledge about the national and international guidelines related to Good Clinical Practices (GCP), and able to apply them during the conduct of clinical trial related activities.
• The graduates will develop skills and knowledge about the national and international regulations related to drug development, data management, clinical trials and pharmacovigilance.
• The graduates will develop skills to prepare and conduct audits and inspections by the regulators, monitors and ethics committees.
• The graduates will develop knowledge and skills in communication and liaisoning with different internal and external agencies/departments (Sponsors, regulators, monitors, ethics committee, vendors, laboratories, diagnostic centres, printers, and suppliers)
• The graduates shall develop acumen for consistent professional and technical growth to become expert professionals in the fields of clinical research (CR), data management and pharmacovigilance (PV).
• Continue to evolve their knowledge and skills during the ever-changing clinical research industry to cope with the technological advancements, clinical discoveries and social needs through self-study and pursuit of higher education.

Professionally competent to perform all clinical trial activities, clinical trial data management and drug safety reporting.
The successful completion of a B.Sc. in clinical research, data management and pharmacovigilance allow the graduates with several benefits.

They will be able to:

• Work as clinical research (CR) professional in pharmaceutical companies in clinical research department.
• Work as CR professionals in contract research organizations (CRO) as Clinical Research Associates (CRA) and monitors.
• Work as CR professionals in site management organizations (SMO) as Clinical Research Coordinators (CRC).
• Work as CR professionals (CRC) at clinical trial sites like hospitals, clinics and bioavailability centres.
• Work in data management organizations as data executives and data managers.
• Apply their knowledge and skills to develop case record forms (CRF) and informed consent documents (ICD).
• Work as Pharmacovigilance (PV) professionals in various pharmaceutical companies (PV department), CRO’s and PV service organizations.
• Conduct standardized database and testing procedures for data validation, adverse event (AE) reconciliation, and medical coding of AE.
• Understand regulations and perspectives of all clinical trial related activities.
• Understand professional and ethical responsibilities in the field of clinical research.
• Adapt to the working environment and participate in all interdisciplinary and multidisciplinary healthcare communities actively and lead as per need.
• Communicate efficiently by verbal and non-verbal methods with all stake holders.
• Understand the evolving regulations, standards, and practices of GCP during conduct of clinical trials.
• They graduates will be capable of working with the advanced technology in clinical trials and provide efficient research solutions with professional and ethical uprightness and socio-economic concerns.