M.Sc in PHARMACOVIGILANCE & CLINICAL RESEARCH

In Collaboration With Parexel

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.

Course Duration

  • 2 Year Masters Program
  • 1.5 years intensive learning at Chitkara University along with Industry specific courses from Parexel
  • 6 months - industry training and internship program

Industry Partner

As part of the curriculum, selected students will get the opportunity for a 6 months internship with Parexel

Campus Recruitment

Assured placement assistance in top Pharmaceutical & Clinical Research Organisations of the world

Eligibility

  • 50% in B.Sc.(Medical/Non medical/ Biotech/Nursing) | B Pharm | BDS | MBBS

Program Highlights

Join the 2-Year Master’s program at Chitkara University and get highly specialised industry endorsed training to become Pharmacovigilance Professionals who are in high demand across the Pharma & Pharmacovigilance industry.

Transform Your Career With Parexel

Get a solid base with 1.5 years of intensive learning at Chitkara University and further build on this solid foundation through the 6 months internship program at Parexel

Learn the most in-demand and contemporary skills

Since It has been mandated by Law for all Pharmaceutical companies to track the safety of Medicines, it has become one of the fastest growing career options.

Conducted by University,
managed by Industry

The Pharmacovigilance program based on International Regulatory & Industry Standards is blended with real world inputs from Parexel in the form of practical modules & use of online softwares for clinical data management.

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Best-in-class content by leading faculty and industry leaders in the form of videos, cases and projects

  Download Syllabus

M.Sc - Pharmacovigilance
& Clinical Research

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.

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.

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.

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.

Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram.

Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.

After The Program You Could Be A

  • Pv. Scientist
  • Pv. Quality Reviewer
  • Pv. Quality Analyst
  • Pv. Medical Safety Writer
  • Pv. System Specialist

Top Bluechip Pharmaceutical & Clinical Research Organisations Hire Chitkara University Graduates

About Chitkara University

In the year 2002, Chitkara Educational Trust established its Punjab campus 30 kilometres from Chandigarh, on the Chandigarh–Patiala National Highway. In the year 2010 Chitkara University was established by the Punjab State Legislature under “The Chitkara University Act”.

Chitkara University, the best university in Punjab is a government-recognized university with the right to confer degrees as per the Sections 2(f) and 22(1) of the UGC Act, 1956.We have launched full- time pathway degree programs in Academic Mentorship with some leading colleges and Universities of the world so that our students get access to globally relevant curriculum, and exposure to accomplished international faculty.

I’m Interested in This Program

FOR MORE INFORMATION, CALL- 95011 05714

CHITKARA UNIVERSITY

Chandigarh-Patiala National Highway
Punjab 140 401

ADMISSIONS HELPLINE

1800 267 1999
9859000000

admissions@chitkara.edu.in