* Started in 2019
Postgraduate program with a strong focus on boosting the expertise in the evaluation of medicines, while providing intensive technical exposure in regards to Clinical Research and Drug Safety prospective, with specialisations in ICSR Processing / Quality Management / Medical Safety Writing & Compliance Management.
PROGRAM OVERVIEW
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.
CAMPUS RECRUITMENT
Continuous interaction with industries including leading Pharmaceutical companies and CROs nationally and internationally and other government organisations for academic, conferences and placements is a special feature during this program. The second-year specializations in ICSR Processing/Quality Management/Medical Safety Writing & Compliance Management, with related projects and INTERNSHIPS are carried out in industry settings, either in association with a clinical research organisation or a Pharmaceutical company.
PHARMACOVIGILANCE Graduates can work as:
- Pharmacovigilance Scientists
- Pharmacovigilance Quality Reviewers
- Pharmacovigilance Quality Analysts
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- Pharmacovigilance Medical Safety Writers
- Pharmacovigilance System Specialists
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SOME OF THE MAJOR COMPANIES WHO RECRUIT PHARMACOVIGILANCE PROFESSIONALS ARE:
PHARMA COMPANIES:
ABBOT, ALKEM, ASTRA ZENECA, ARISTO, BAYER, BRISTOL-MYERS SQUIBB, CADILA, DABUR, ELLYLILLY, GLAXO, J&J, MERCK, NICOLAS PIRAMAL, NOVARTIS, NOVO NORDISC, PANACEA, PFIZER, RANBAXY, SANOFI AVENTIS, SERDIA, SOLVAY, SUN, WOCKARDT, DR.REDDY’S, AUROBINDO, NATCO ETC
CLINICAL RESEARCH ORGANIZATIONS:
PAREXEL, IQVIA, COVANCE, ACCUTEST, APOTHECARIES, CLININVENT, CLINIRX, GVK BIOSCIENCES, I3 RESEARCH, IGATE, NEEMANS, QUEST, RELIANCE, SIRO CLIN PHARM, SYNCRON VEEDA, ASTRAZENCA ETC
HOSPITALS:
APOLLO, AIIMS, ASIAN HEART INSTITUTE, BOMBAY HOSPITAL, ESCORTS, FORTIS, HINDUJA HOSPITAL, MAX, TATA MEMORIAL HOSPITAL, RAJIV GANDHI CANCER HOSPITAL, ETC
BPOS/KPOS:
ACCENTURE, COGNIZANT, HCL, IBM, INFOSYS, TCS, WIPRO, ETC
PROGRAM HIGHLIGHTS
For this academic year we are offering the following 2-Year Masters Degree in Pharmacovigilance with specializations in:
Advanced ICSR Processing Read More
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.
Pharmacovigilance Quality Read More
This Program leads to specialisation in Quality management in Pharmacovigilance, which is an integral part of the good pharmacovigilance practices. These processes deal with the Quality management system procedures and processes, and documentation, Monitoring and planning.
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 Pharmacovigilance Quality Management including system procedures and processes, documentation, Monitoring and planning and Communication, Action and Training along with minimum of 3 months internship in Pharmacovigilance department of leading Pharma companies and CROs.
Pharmacovigilance Medical Safety Writing Read More
This Program offers a specialisation in the aggregate report writing including PSURs, PBRERs, PADERs etc., its technical aspects, management, writing and analysis. This specialization offers exposure to writing PSURs, PBRERs, PADERs etc including Format and Structure, Data management and Analysis, Processing and Reporting and Quality Reviews. The second-year projects touch upon writing different reports along with minimum of 3 months internship in Pharmacovigilance department of leading Pharma companies and CROs.
Pharmacovigilance Compliance Management Read More
This Program offers a specialisation in the Pharmacovigilance Regulations & Compliances nationally and internationally including Pharmacovigilance Agreements, Pharmacovigilance System Master File (PSMF), Pharmacovigilance System Management, Pharmacovigilance Training and Quality Management Pharmacovigilance and Risk Management Systems and Pharmacovigilance Audit & Inspections. This specialization offers exposure to Global Pharmacovigilance Regulations and develops competencies on Pharmacovigilance System Management. The second-year projects touch different aspects of Pharmacovigilance System Management along with minimum of 3 months internship in Pharmacovigilance department of leading Pharma companies and CROs.
Eligibility & Fees
Eligibility
- B.Sc. | B Pharm with a minimum aggregate of 50%
- Personal interview.
Fees
| Per Semester |
Rs. 77,000 |
| ERP* |
Rs. 8,000 |
The fees for any of the above programs is subject to revision.
*ERP: Only at the time of admission.
