M.Sc in PHARMACOVIGILANCE & CLINICAL RESEARCH In Collaboration With Parexel at Chitkara University

The 2-year Master degree program in Pharmacovigilance is aimed at creating skilled and competent Pharmacovigilance professionals who can work effectively at different levels in Pharmacovigilance departments of leading Pharma companies and Clinical Research Organizations (CROs) worldwide. This program lets the students learn from the industry experts to get internationally compliance Pharmacovigilance training based on defined Pharmacovigilance Competency Frameworks (PCF). The curriculum includes in-depth study of Pharmacovigilance related processes, complimented with hands on training on ICSR processing, Quality management, aggregate report (PSUR/PBRER/ PADER etc.) writing and compliance management, and in turn help students develop internationally accepted competencies to become world-class Pharmacovigilance Professionals.

The Masters in Pharmacovigilance with specialization as Advanced ICSR Processing lead to hands on training on Pharmacovigilance E2B Compliance Database along with MedDRA and WHO-DD coding which are essential specialisations for ICSR processing in Pharmacovigilance system. The first year involves theoretical and practical sessions in the following areas: General Pharmacology; Adverse Drug Reactions and Clinical Therapeutics; Pharmacovigilance in Clinical Trials; Pharmacovigilance System & Regulations – ICH, GVP, 21 CFR, CIOMS etc.; WHO Programme for International Drug Monitoring; Pharmacovigilance – Sources of ADRs (ICSRs); Pharmacovigilance Data Management; Signal Management and Regulatory Reporting in Pharmacovigilance; Pharmacovigilance Risk Management; and Pharmacovigilance Audit & Inspections. The second-year projects touch upon advanced level of ICSR processing, different Case studies, and process management along with minimum of 3 months internship in Pharmacovigilance department of leading Pharma companies and CROs.

SUNIL VERMA, Pharmacovigilance Specialist

Sunil is a qualified MBA and Pharmacy professional with over 12 years of experience in Pharmaceutical industry especially in the areas of Pharmacovigilance and Clinical research. Sunil is currently leading GRATISOL Lab’s training and consultancy company (Academy of Clinical Intelligence) as Director in Chandigarh region. Prior to that, he was Global Clinical Pharmacovigilance Manager for ADI Group, during which he initiated the development of the company’s Pharmacovigilance quality management system for its clinical development programme. In this role, he was responsible for Pharmacovigilance, medical information and clinical development. He also has experience as consultant to develop companies core Pharmacovigilance activities for audit purpose.

Sunil has also been involved in training throughout his career particularly in the areas of Pharmacovigilance including ARGUS Safety, Clinical Research and Medical Writing. With over 10 years of experience in the pharmaceutical industry and clinical research organization, he offer his clients the assurance that their drug safety training programs are being conducted by a seasoned Pharmacovigilance executive with experience in developing, implementing and leading safety trainings in lower cost markets.

Client certified trainer – with 5 years of varied industry experience to conduct training for Pharmacovigilance processes including ARGUS Safety, MedDRA and WHO Drug Dictionary and case processing in Pharmacovigilance.