Signal Assessor

We are currently looking for Associate Signal Assessors to join ourPatient Safety and Monitoring Team within the Safety & Surveillancegroup. 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 promotionbasis. 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

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 new Safety and Surveillance Group brings together into a single integrated structure devices and medicines safety expertise with enforcement capabilities. These functions will be supported by our data and evidence generating capabilities complementing our signal generating capabilities produced via the new Safety Connect System.

Medicines and devices have traditionally been regulated separately largely driven by different regulatory processes and ways of working but the consequence is a failure to capture on synergies and expertise and a duplication of effort in signal detection infrastructure data capture and communications. As science and technology drives increasing understanding of disease it is also opening new opportunities for treatments with both medicines and devices. As a result product profiles are changing becoming ever more complex and the boundaries between medicines and devices are blurring. These changes provide a unique opportunity to bring medicines and devices capabilities together to better address the regulatory challenges of the future. Against this background and the drive to improve treatment availability for patients safety remains at the heart of our decision making. As such the central mission of the Safety & Surveillance portfolio is to protect the public from risks associated with medicines and medical devices by:

• Ensuring a world class comprehensive vigilance system that can promptly detect and monitor signals across the product life cycle

• Evaluating the benefit risk of signals and developing effective and measurable risk mitigation measures

• Deploying innovative interventions to reduce the criminal threat

• Exploiting data and embracing new technologies to develop the evidence to support our actions and understand their impact

The Patient Safety Monitoring Function is responsible for developing and delivering a world class vigilance system to detect and monitor safety signals for medicines medical devices vaccines and blood products.

Whats 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.

Who are we looking for

Oursuccessful candidatewill 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 candidatesfind out more here.

• Online application form including questions based on theBehaviour 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 theBehaviour 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 allowsufficienttime. You can view the competencies for this role in the job description.

Use of AI in Job Applications

Applicants must ensure that anything submitted is 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 as soon as possible.

Closing date:7th September 2025

Shortlisting date: 15th September 2025

Interview date:Week commencing 29th September 2025

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 questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must completebasic personnel security standard checks.

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.

Applicants who are successful at interview will be as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicants details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes including Tax-Free Childcare. Determine your eligibilityhere.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint you should firstly contact Florentina Oyelami Head of Talent Acquisition.

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ