2 YEARS
MASTER DEGREE IN
PHARMACOVIGILANCE
Affiliated to
CHITKARA UNIVERSITY
PROGRAM OVERVIEW
The MSc in Pharmacovigilance is a course developed by the Chitkara University in collaboration with Pharmacovigilance Industry training partner. In this course students will learn and develop relevant skills used in Pharmacovigilance industry to come out as Pharmacovigilance professional.
This one of its kind and professional development course is globally recognized with great opportunity for graduates to stay on top of in Pharmacovigilance industry.
About
Pharmacovigilance
Pharmacovigilance is an excellent employment option for pharmacy, medical and life science graduates. It is a scientific discipline that is generally involved with reporting and assessing side effects of medicine. It is mainly due to the function of Pharmacovigilance professionals that the medicines in the market place that we consume are generally safe and all those that are identified hazardous are taken off the market.
Pharmacovigilance professionals constantly monitor the safety of the medicines in clinical trials as well as the medicines previously being marketed in the market. Just after a medicinal side effect is reported, the Pharmacovigilance professionals enter the event in appropriate databases, follow-up with the event to collect additional information and send these reports to regulatory authorities and other appropriate regulatory bodies.
JOB
Opportunities
- Pharmaceutical Companies (MNCs & Indian) & Biotech companies
- Clinical Research Organizations
- KPOs/BPOs
- Regulatory Agencies like IPC & CDSCO
- Pharmacovigilance units in Medical colleges & Hospitals
A Degree conducted by UNIVERSITY and managed by INDUSTRY
PROGRAM DETAILS
OBJECTIVES
- Acquisition of knowledge and skills through a combination of directed reading, lectures, workshops, technical hands on training based on real-life examples, problem based exercises and assignments
- Throughout, the students are encouraged to undertake technical exposure through practice based learning both to supplement and consolidate what is being taught/learnt and to broaden their individual knowledge and understanding of the subject.
- Knowledge and understanding are combatively assessed through a combination of in course assessments in the form of in-class tests, assignments and workshop based exercises.
- Technical skill will be assessed through analysis of case studies, unseen in-course assessments, assignments and project work.
COURSE STRUCTURE
SEMESTER I:
- General Pharmacology
- Adverse Drug Reactions by Major Body Systems
- Pharmacovigilance in Clinical Trials
- Pharmacovigilance System & Regulations – ICH, GVP
- WHO Program for International Drug Monitoring
- Fundamental Clinical Aspects of ADRs
SEMESTER II:
- Pharmacovigilance – Sources of ADRs (ICSRs)
- Pharmacovigilance Data Management – I
- Pharmacovigilance Data Management II – HAROM Safety Suit 1.0.1 – Pharmacovigilance E2B Compliance Database
- MedDRAv20.1 Coding
- Signal Detection and Management
- Regulatory Reporting in Pharmacovigilance
- Pharmacovigilance Risk Management
- Pharmacovigilance Audit & Inspections
SEMESTER III:
- SPECIALIZATION I: Advanced Pharmacovigilance Data Management
- SPECIALIZATION II: Pharmacovigilance Medical Safety Writing
- SPECIALIZATION III: Pharmacovigilance Quality Management
- SPECIALIZATION IV: Pharmacovigilance Compliance Management
SEMESTER IV:
- Pharmacovigilance and Risk Management Systems
- Project
- Thesis
- Dissertation
- Exit Interview
- Internship
COURSE DURATION
- 2 YEARS – FULL TIME/PART TIME
ELIGIBILITY
- FULL TIME: B. PHARMACY | B. TECH/BSc (Life Sciences) | BSc (Medical/Nursing)
- PART TIME: Working Professionals
CONTACT
For Admission related Enquiries:
9988756469 | 95011-05714 | 95011-05715
admissions@chitkara.edu.in
Chitkara University Campus
Chandigarh-Patiala National Highway (NH-64)
Punjab- 140 401, India
