Benefit Risk Evaluation Assessor – Biological Safety

We are currently looking for a Benefit Risk Evaluation Assessor Biological Safetyto join our Benefit Risk Evaluation I Team within the Safety & Surveillancegroup.

This is a full-timeopportunity on a permanent 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

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 Safety and Surveillance (S&S) Group brings together into a single integrated structureexpertiseon the safety of all medical products with enforcement capabilities. These functions are supported by the Agencys data and evidence generating capabilities complementing our signal generating abilities.

Against this background and the drive to improve treatment availability for patients safetyremainsat the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriatelyidentifyingassessingand managing the risks associated with medical every aspect of this work we harnessthe best science technologyinformationand professional practice to protect patients in new and impactful ways.

The core purpose of Benefit Risk Evaluation is todelivera robust assessment of potential safety signals using data from a range of sourcesalong withtechnical scientificclinicaland regulatory knowledgeandpractical teamconducts benefit-risk evaluations for medicines and medical device across a broad spectrum of therapeutic areas to guide actions that protect patient safety. The teamis responsible for:

• Signal detection of emerging safety issues

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

• Usingdata and embracingnew technologiesto develop the evidence to support our actions and understand their impact

Whats the role

We haveanexciting opportunitywithin the Benefit-Risk Evaluation group a criticalcomponentof Safety and to theBiosafety Nonclinical and Emerging TechnologiesTAU Headthe assessor willprovide technical and regulatoryexpertiseonbiological safetymattersto theBenefit Risk Evaluation Group theClinical InvestigationsGroup and across MHRA. The post holderisrequired towork collaboratively with other benefit risk assessors acrossthe group to provideexpert advice and directionto investigationson biological safety holder will alsolead on the assessment of biological safety for clinicalinvestigationsand whereappropriatethe development ofguidance.

Key responsibilities:

• Activelyparticipatein meetings and work programmes to assessand investigatesafety signals involvingbiological safety; effectivemanagement ofsafety issuesensuringrelevantassessorsare keptup-to-date and quality of work ismaintained.
• Providespecialist technical advice and support onbiological safetyto othercolleagues and senior officials to meet divisional business needs and targets.
• Undertaketechnical reviewsofbiological safety issuesasrequiredon new and emerging safety signals and/or new and emerging data/evidenceand make recommendations for actions to protect patients.
• Commitment to continuousdevelopmentin the area ofbiological safety and toxicology

Who are we looking for

Oursuccessful candidatewill have the following:

• Degree or equivalent qualification inlife scienceshealthcareor engineering(such as medical engineeringtoxicologymaterial science or healthcare qualification); andpreviousrelevant experience gained in healthcare medical device manufacturing regulatory environment or health data science.

• Technical knowledge or practical experience ofa range ofmedical devicesincluding knowledge and experience ofstandards inbiological evaluation and risk management of medical devices

• Experience of critically analysing complex clinical/scientific/technical information froma number ofsources under pressure and makeappropriate recommendationsor decisionsto protect patient safety/public health even when the evidence is not clear. Experience of implementing appropriate actions to mitigate risk.

• Evidence of writing well-structured concise authoritative reports to support decision making on device safety and provide technically sound information to stakeholders.

• Knowledge and understanding of therelevant regulatory frameworks including provisions related to biological safety

Person Specification:

Method of assessment: AApplication PPresentation IInterview

Behaviour Criteria:

• Managing a Quality Service (A)

• Communicating and Influencing(A I)

• Seeing the Big Picture(A I)

Experience Criteria:

• Proven understanding of risk management principles to reduce harm (direct or indirect) preferably related to biological safety (P)

• Experience of conducting benefit/ risk evaluations for medical devices with considerations for biological safety (P)

• Experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressure and make appropriate recommendations or decisions to protect patient safety/public health even when the evidence is not clear. Implement appropriate actions to mitigate risk (A)

• Evidence of writing well-structured concise authoritative reports to support decision making on drug / device safety and provide technically sound information to stakeholders (I)

• Evidence of delivering clear and focussed presentations that are tailored to the needs of the audience(P)

Technical Criteria:

• Degree or equivalent qualification in life sciences health care or engineering (such as medical engineering toxicology material science or healthcare qualification) and previous relevant experience gained in healthcare medical device manufacturing regulatory environment or health data science.(A)

• Technical knowledge or practical experience of a range of medical devices including knowledge and experience of standards in biological evaluation (ISO 10993 series) and risk management of medical devices (ISO 14971)andknowledge and understanding of the relevant regulatory frameworks including provisions and relevant guidance related to biological safety.(A I)

Strengths Criteria:

• Adaptable (I)

• Team Player (I)

• Analytical (I)

If you would like to find out more about this fantastic opportunity please readour 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.

• 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 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:Technical knowledge or practical experience of a range of medical devices including knowledge and experience of standards in biological evaluation (ISO 10993 series) and risk management of medical devices (ISO 14971) and knowledge and understanding of the relevant regulatory frameworks including provisions and relevant guidance related to biological safety.

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

Use of AI in Job Applications

Artificial Intelligence can be a useful tool to support your application however all examples and statements provided must be truthful factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others or generated by artificial intelligence as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see ourcandidate guidancefor more information on appropriate and inappropriate use.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:11 January 2026

Shortlisting date: 26 January 2026

Interview date:Week Beginning 02 February 2026

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