Details Reference number 351144 Salary £75,000 A Civil Service Pension with an average employer contribution of 27% GBP Job grade SCS Pay Band 1 Contract type Fixed term Length of employment FTC until September 2025 Business area MHRA - Safety and Surveillance Group Type of role Medical Working pattern Full-time Number of jobs available 1 Contents Location About the job Benefits Things you need to know Apply and further information Location London About the job Job summary We are currently looking for a Expert Benefit Risk Evaluation Assessor to join our Gastrointestinal System, Nutrition Endocrine and Fertility Benefit Risk Evaluation team within the Safety and Surveillance Group. This is a full-time opportunity, on a fixed term contract to September 2025. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas. We are currently operate a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Who are we? 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 core objective of the Safety & Surveillance Group is to protect the public from risks associated with medicines and medical devices. The vacancy sits within the Gastrointestinal System, Nutrition Endocrine and Fertility Benefit Risk Evaluation team and arises due a number of ongoing high profile Agency delivery plan objectives focussed on Womens Health topics as well as a high volume of business as usual activities across the full remit of the team such as benefit risk assessments, product license variations and risk management plan reviews. This fixed term role until the end of September 2025 will contribute to ongoing, complex workstreams across the product portfolio, with the scope for cross Agency working including with Partnerships and Communications and external stakeholder work. There will be the opportunity to be involved in delivering regulatory strategies to tackle womens health inequities as well as other high-profile work on womens health issues. The experience of the successful applicant will be vital in helping to support new members of the team build their competencies. Conduct assessments of balance of benefits and risks of medicines and/or medical devices in response to potential safety signals and/or new data Make evidence-based recommendations for action to minimise risk and maximise benefit Take action to reduce newly identified risks associated with medicines and medical devices by updating licences/recommending changes to instructions for use/recommending field safety corrective actions Assess relevant licensing applications, devices clinical investigation applications, performance studies or Exceptional Use Authorisations as required and applicable in conjunction with SRI Person specification Candidate will have extensive and in depth knowledge of the regulation of medicines in the UK (UK HMR 2012) Highly experienced in analysing and critically appraising clinical/scientific/technical information from a number of sources, including writing reports/papers and presenting at and/or chairing expert committees Be able to work collaboratively with customers and delivery partners to manage, monitor and deliver agreed outcomes Provides clarity about the action required to achieve results and address unexpected developments Influence external partners, stakeholders and customers successfully securing mutually beneficial outcomes If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careersmhra.gov.uk Benefits Alongside your salary of £75,000, Medicines and Healthcare Products Regulatory Agency contributes £20,250 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides. Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays Privilege Leave: 1 day Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666 Flexible working to ensure staff maintain a healthy work-life balance Interest free season ticket loan or bike loan Employee Assistance Services and access to the Civil Service Benevolent Fund Eligibility to join the Civil Service Motoring Association (CSMA) Variety of staff and Civil Service clubs On-going learning and development Things you need to know Selection process details We use the Civil Service Success Profiles to assess our candidates, find out more here. Online application form, please attach a supporting statement. Applicants are asked to demonstrate in no more than 2 sides of A4 how they meet the Behaviours (managing a quality service, deliver at pace, communicating and influencing), Experience and Technical aspects of the person specification. demonstrating how you meet the person specification. Please attach as a PDF. Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage. Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles. Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the statement of suitability provided. You can view the criteria for this role in the job description. Applicants must ensure that anything submitted must be factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own. If you require any disability related adjustments at any point during the process, please contact careersmhra.gov.uk as soon as possible. Closing date: 12th May 2024 Shortlisting date: from 13th May 2024 Interview date: from the 20th May 2024 Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome. If you need assistance applying for this role or have any other questions, please contact careersmhra.gov.uk Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available