Location: City of Westminster, London
Grade and salary: SEO - £37,922
Contract type: Fixed term 18 months
The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The agency is made up of circa 1300 staff working across two main centres and peripatetically across the UK and abroad.
The MHRA consists of Vigilance and Risk Management of Medicines (VRMM), Licensing, Devices and Inspection, Enforcement & Standards (IE&S). The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
The Vigilance and Risk Management of Medicines Division protects public health by ensuring the safety, quality and efficacy of medicines, including the provision of information to promote safe and effective use. VRMM conducts post-marketing surveillance and operates the Yellow Card Scheme for reporting, and monitoring adverse reactions to medicines. We take any necessary action to safeguard public health, for example through safety warnings or removing or restricting the availability of products.
Purpose of the role:
Monitoring the outcomes following a regulatory decision, in particular those leading to risk minimisation measures, or a change in clinical practice is one of the key steps within the pharmacovigilance cycle needed to ensure a positive benefit risk balance. In order to help protect public health it is vital that regulators have access to robust data allowing us to monitor the use of medicines and devices in routine practice to ensure that any actions have had the desired impact on clinical management and have been effective in minimising risk and maintaining a positive benefit risk balance.
This is a joint role with the Clinical Practice Research Datalink (CPRD). CPRD, jointly funded by the agency and the National Institute of Health Research (NIHR), is the UK’s preeminent research service providing access to anonymised NHS data for research. CPRD services are designed to maximise the way anonymised NHS clinical data can be used to improve and safeguard public health. For more than 20 years data provided by CPRD have been used in a range of drug safety and epidemiological studies that have impacted on health care and resulted in over 1500 peer-reviewed publications. The UK is in a unique global position to use clinical records in novel ways for patient recruitment, clinical trials management and follow up. In addition to supporting high quality observational research, CPRD is developing world leading services based on using real world data to support clinical trials and intervention studies.
Accountable to the Pharmacoepidemiology Unit Manager in the Vigilance and Risk Management division of the MHRA, this role will work within VRMM in close collaboration with the CPRD undertaking specific epidemiological projects to:
• Assess the impact and effectiveness of regulatory actions taken to ensure that medicines are used safely and effectively in the UK
• Inform and develop the methods and capabilities for outcomes monitoring within the CPRD set of Research services.
How to apply:
You can find further information and apply for this position by creating a job profile on the Civil Service Jobs portal here: http://bit.ly/1Ph7GXZ. Please ensure to review the full job description and competencies in relation to this position prior to applying. Applicants will be expected to meet and address all the competencies in order to be shortlisted for the interview stage.
We are an equal opportunities employer and welcome applications from suitably qualified people regardless of age, gender, sexual orientation, marital status, race, religion, politics or disability. All civil servants work within the boundaries of the Civil Service Code. The Code sets out the duties and responsibilities of all civil servants. Please click on the link for more information: https://www.gov.uk/government/publications/civil-service-code/the-civil-service-code.
The closing date for applications is 21st February 2016.
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