Benefit Risk Evaluation Assessor

We are currently looking for aBenefit Risk Evaluation Assessorto join ourOncology Haematology and Thrombotic disease team part of Benefit Risk Evaluation Iwithin the Safety & Surveillance group.

This is a full-timeopportunity on a permanent basis. The role will be based in 10 South Colonnade Canary Wharf London E14 4PU.

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 Group brings together into a single integrated structure devices and medicines safetyexpertisewith enforcement capabilities. These functions are supported by our data and evidence generating capabilities complementing our signal generating capabilities produced via the new Safety Connect System.

Safetyremainsat the heart of our decision making. As such the coreobjectiveof the Safety & Surveillance Group 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 andmonitorsignals across the product life cycle.

• Evaluating the balance of benefits and risks for medicines and medical devices assessing signals and developing effective and measurable risk mitigation measures.

• Deploying innovative interventions to reduce the criminal threat.

• Exploiting data and embracingnew technologiesto develop the evidence to support our actions and understand their impact.

The Oncology Haematology and Thrombotic disease team monitors safety of medicines and medical devices across these therapy areas. A significant focus of the team is to support approval of novel therapies through effective risk management assessing plans for further characterisation post-marketing of potential safety concerns and maintaining product licences ensuring effective minimisation of risks as new information on the safety of the products in our portfolio emerges.

Whats the role

The core purpose of this role is to provide robust benefit risk assessments and review safety signals using data from a range of sources and technical scientific clinical and regulatory knowledge and/or practical experience. Benefit risk assessorsare responsible forengaging with a range of stakeholders including patients and the public to maketimelyand robust benefit-risk assessments and recommend safety actions and risk mitigations that are outcome focused.

Benefit/risk assessors are flexible according to business needs and work across therapeutic teams and the wider agency and the health and social care system to respond promptly to potential safety issues and protect patient safety.

All benefit risk roles require working flexibly to perform and contribute to benefit risk assessments across allmedicine and medical deviceproducts asrequired.

Key responsibilities:

• Conduct robust assessments regarding medical devices and medicinal products in relation to emerging safety signals utilising a range of data sources.

• Be proactive in engaging with all stakeholders including patients and the public health care professionals and companies to complete benefit risk evaluation assessments.

• Recommend timely and proportionate regulatory actions to enhance benefit and mitigate potential residual patient safety risks; this may include the development of impactful safety messages.

• Work in a matrix way to conduct benefit risk assessments and as required assess clinical investigation applications Exceptional Use Authorisations Medicinal Product Variations Risk Management Plans to set deadlines.

• Keep accurate records of benefit risk assessments and decisions as required.

• Contribute to and lead projects across the product life cycle to ensure compliance with regulations and contribute to assessing the impact of regulatory decisions on protecting patients and ensuring public health.

Who are we looking for

Oursuccessful candidatewill have the following:

Behaviours

• Communicating and influencing - Communicate in a straightforward honest and engaging manner choosingappropriate stylesto maximise understanding and impact. Ensure communication has a clear purpose andtakes into accountpeoples individual needs. Share information asappropriateand check understanding.

• Making Effective Decisions - Display confidence when makingdifficult decisions even if they prove to be unpopular. Consult with others to ensure the potential impacts on end users have been considered. Gain a clear understanding of stakeholders needs and expectations. Act to prevent problems and provide solutions.

Experience

• Proven understanding of risk management principles to reduce harm (direct or indirect).

• Technical knowledge and/or practical experience of a range of medical devices and/or medicines within a therapeutic area

• Proven experience of managing complex projects to agreed milestones managing conflicting priorities and the work of others.

• Proven experience in conducting benefit risk evaluations of medical devices and or medicines is desirable

Technical

• Degree or equivalent qualification in a related discipline (such as physical and/or biological sciences pharmacy engineering or a relevant healthcare qualification)

• Previousrelevant experience such as healthcare medical device or medicinal product manufacturing regulatory environment clinicalresearchor equivalentis desirable.

Person Specification:

Method of assessment:AApplication IInterview

Behaviour Criteria:

• Communicating and Influencing (A I)

• Making Effective Decisions (A I)

Experience Criteria:

• Proven understanding of risk management principles to reduce harm (direct or indirect). (A I)

• Technical knowledge and/or practical experience of a range of medical devices and/or medicines within a therapeutic area (A I)

• Proven experience of managing complex projects to agreed milestones managing conflicting priorities and the work of others. (A I)

• Proven experience in conducting benefit risk evaluations of medical devices and or medicines is desirable(A I)

Technical Criteria:

• Degree or equivalent qualification in a related discipline (such as physical and/or biological sciences pharmacy engineering or a relevant healthcare qualification) (A I)

• Previousrelevant experience such as healthcare medical device or medicinal product manufacturing regulatory environment clinicalresearchor equivalentis desirable.(A 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.

• 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 Experience criteria.

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

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:31 May 2026

Shortlisting date: 03 June 2026

Interview date:16 & 17 June 2026

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.

Individuals appointed on level transfer will retain their existing salary and are responsible for ensuring they fully understand the financial implications of any potential move and the impact (if any) on their terms. If an individual is in any doubt they should seek clarification before accepting a job offer.

Staff joining on promotion will receive up to a 10% increase of their current basic salary or the pay band minimum whichever is the greater.

The individual will not retain any allowances paid by the former department/Agency unless there are special circumstances such as a reserved right to those allowances on transfer.

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

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