Pharmacovigilance Data Management

Start: October

Duration: 1 year full-time, 2-3 years part-time.

Entry Requirements:

A good Honours degree from a UK university or equivalent in a relevant discipline. Where applicable, students must achieve a minimum International English Language Testing System (IELTS) score of 6.5 or Test of English as a Foreign Language (TOEFL) score of 92. Our Pre-sessional English for Academic Purposes courses offer pre-sessional training in English.

Course Description:

Pharmacovigilance is the discipline of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, with a view to preventing harm to patients.

Pharmacovigilance plays a vital role within the clinical trials process, helping to ensure the development of safe drugs that meet required European and International regulations. It can also significantly reduce the time it takes for drugs to reach the market and reduce drug recalls which are a substantial financial burden to pharmaceutical companies.

The increasing volume of data produced during clinical trials has produced a need for specialised professionals who can effectively manage, analyse and interpret pharmacovigilance data with a view to advising healthcare professionals on the safe and effective use of medicines in practice.

Our unique Pharmacovigilance Data Management MSc will provide an understanding of the detection and assessment of adverse effects of medicines (both long and short term), with an emphasis on the data management requirements involved in clinical trials, and the skills and capacity to identify, store, extract and analyse large volumes of clinical data in a secure manner.  

Our Pharmacovigilance Data Management MSc is part of the Clinical Research Programme and is divided into three parts:

• a formal taught component comprising eight modules
• a group project  
• an individual research project.

Modules:

• Translation of New Medicinal Products into the Clinic
• Research Design and Methodology
• Statistical Analysis and Interpretation
• Clinical Trial Practice
• Business Principles
• Information Warehousing
• Data Systems
• Regulatory Affairs

Group project

This follows the taught modules. Students will work in small teams on a project requiring the use of all knowledge and skills gained from the taught modules.

Research project

A critical part of the course is the four-month individual research project, enabling you to apply the theory, processes, methods, skills and tools gained on the taught programme.

Funding:

Please contact Enquiries for information on funding. Please note that a formal offer of a place on this course must have been received before consideration can be given for funding.

For further information, please contact Enquiries tel: 01234 758008 or email enquiries.health@cranfield.ac.uk

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