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Job Post Details

Benefit Risk Evaluation Assessor - Biological Safety - £60,778 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency
·
3.8
10 South Colonnade, London
£60,778 a year
Permanent, Full-time

Job details

£60,778 a year
Childcare, Annual leave, Sick pay, Company pension, Season ticket loan
Permanent, Full-time
10 South Colonnade, London

Full job description

Details

Reference number

442413

Salary

£60,778
A Civil Service Pension with an employer contribution of 28.97%
GBP

Job grade

Grade 7

Contract type

Permanent

Business area

MHRA - Safety and Surveillance Group

Type of role

Operational Delivery

Working pattern

Flexible working, 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 Benefit Risk Evaluation Assessor – Biological Safety to join our Benefit Risk Evaluation I Team within the Safety & Surveillance group.

This is a full-time opportunity, 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 structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agency’s data and evidence generating capabilities, complementing our signal generating abilities.

Against this background and the drive to improve treatment availability for patients, safety remains at 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 appropriately identifying, assessing and managing the risks associated with medical products. In every aspect of this work, we harness the best science, technology, information and professional practice to protect patients in new and impactful ways.

Job description

The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical, scientific, clinical and regulatory knowledge, and practical experience. The team conducts benefit-risk evaluations for medicines and medical device across a broad spectrum of therapeutic areas to guide actions that protect patient safety. The team is responsible for:

  • Signal detection of emerging safety issues

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

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


What’s the role?

We have an exciting opportunity within the Benefit-Risk Evaluation group, a critical component of Safety and Surveillance. Reporting to the Biosafety, Nonclinical and Emerging Technologies TAU Head, the assessor will provide technical and regulatory expertise on biological safety matters to the Benefit Risk Evaluation Group, the Clinical Investigations Group and across MHRA. The post holder is required to work collaboratively with other benefit risk assessors across the group to provide expert advice and direction to investigations on biological safety issues. Additionally, the post holder will also lead on the assessment of biological safety for clinical investigations and where appropriate, the development of guidance.


Key responsibilities:

  • Actively participate in meetings and work programmes to assess and investigate safety signals involving biological safety; effective management of safety issues ensuring relevant assessors are kept up-to-date and quality of work is maintained.
  • Provide specialist technical advice and support on biological safety to other colleagues and senior officials to meet divisional business needs and targets.
  • Undertake technical reviews of biological safety issues as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients.
  • Commitment to continuous development in the area of biological safety and toxicology

Person specification

Who are we looking for?


Our successful candidate will have the following:

  • 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.

  • Technical knowledge or practical experience of a range of medical devices including knowledge and experience of standards in biological evaluation and risk management of medical devices

  • 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. 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 the relevant regulatory frameworks, including provisions related to biological safety


Person Specification:

Method of assessment: A=Application, P=Presentation, I=Interview

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) and knowledge 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 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 careers@mhra.gov.uk

Benefits

Alongside your salary of £60,778, Medicines and Healthcare Products Regulatory Agency contributes £17,607 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

Artificial intelligence

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 our candidate guidance for more information on appropriate and inappropriate use.

Selection process details

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.

  • 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.


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 allow sufficient time. You can view the competencies for this role in the job description.

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.


Closing date: 18 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 questions, please contact careers@mhra.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 here.


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 complete basic 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 applicant’s 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 eligibility here.


Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.


In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit 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, Florentina.Oyelami@mhra.gov.uk.


If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk


info@csc.gov.uk

Civil Service Commission

Room G/8

1 Horse Guards Road

London

SW1A 2HQ


Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

  • UK nationals
  • nationals of the Republic of Ireland
  • nationals of Commonwealth countries who have the right to work in the UK
  • nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS)
  • nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
  • individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
  • Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service
Further information on nationality requirements

Working for the Civil Service

The Civil Service Code sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles .
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan and the Civil Service Diversity and Inclusion Strategy .

Apply and further information

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

  • Name : The Resourcing Team
  • Email : Careers@mhra.gov.uk

Recruitment team

  • Email : Careers@mhra.gov.uk

Further information

In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit 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 contact the Resourcing Team at Careers@mhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ
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