We are currently looking for Associate Signal Assessors to join our Patient Safety and Monitoring Team within the Safety & Surveillance group. This role will be within the Vigilance Development team who have a focus on delivering world class vigilance systems.
This is a full-time opportunity, on a 2 year fixed term contract/loan/secondment/internal move or temporary promotion basis. 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.
Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
We are currently implementing 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 LOOKING FOR?

Our successful candidate will have:

• Substantive experience of producing work to high standards of quality within a pressurised time frame; effective use of organisational, multi-tasking skills and prioritising skills to meet tight deadlines.
• Analysing and interpreting complex data and making appropriate recommendations under pressure.
• Experience of putting forward own viewpoints when discussing scientific issues and liaising with both internal and external stakeholders.
• A University degree or equivalent qualification in disciplines such as: pharmacy, medicine, nursing, physiology, pharmacology, toxicology, biological sciences, engineering or other appropriate life science.
• An understanding of the use of information systems involved in the reporting of adverse incidents and signal management to support business processes including sharing information externally with stakeholders.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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THE SELECTION PROCESS:

We use the Civil Service Success Profiles to assess our candidates, find out more here .

• Online application form , including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
• Interview , which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of : Describe a time you have analysed and interpreted complex data and made appropriate recommendations.
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 competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

WHAT’S THE ROLE?

As an Associate Signal Assessor, you will be responsible for capturing adverse incidents for Medicines and Devices onto our database, with vigilance signal detection and assessment being the main focus. These processes are undertaken for medicines and devices to ensure safety issues and risks to public health are identified and evaluated. Additional activities for this role include responding to enquiries from stakeholders and provision of adverse incident data to stakeholders as well as project specific work. The successful applicants will work flexibly across the range of healthcare products.
Signal Assessors will initially be employed at EO level as Associate Signal Assessors. It is expected that after a period of training, of usually twelve to eighteen months, progression to the contracted role at HEO level will take place. Progression to Signal Assessor accreditation will require demonstration of performance of the Signal Assessor skills and knowledge. There may also be opportunities for Associate Signal Assessors and Signal Assessors to rotate to coordinator positions in the Yellow Card Strategy and Vigilance Development Teams depending on personal development and business needs of the Patient Safety Monitoring Function.
Signal Assessors will also be eligible to join the TOPRA Regulatory Affairs Apprenticeship program (equivalent to masters level).

KEY RESPONSIBILITIES:

• Classification and follow-up of adverse incident reports to ensure the accuracy, quality and timely production of vigilance incident cases.
• Vigilance signal detection and evaluation and attendance at review meetings.
• Provide clear, reliable and timely scientific, regulatory advice and data for FOI requests and all types of queries.
• Develop and maintain knowledge across range of product types including for devices their manufacture, development and use including clinical implications.
• To be involved in vigilance additional role work and projects including NHS data review, liaison with our Yellow Card Centres, improvement of electronic incident submission with website and app maintenance and enhancements, vigilance terminology maintenance and engagement with manufacturers.
• Signal assessment for all products, and input into the development of reports for expert committees as required.

Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens
• Maintenance roles, particularly those required to work in laboratory settings
• Roles that involve visiting other establishments where vaccination is required
• Roles required to travel overseas where specific vaccination may be required