Medicines and Healthcare products Regulatory Agency

Senior Benefit Risk Evaluation Assessor x2 - £75,585 - £84,840 p.a. + benefits

London
£75.5k – £84.9k/yr
Posted 2 days ago

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Senior Benefit Risk Evaluation Assessor x2 - £75,585 - £84,840 p.a. + benefits

Canary Wharf, London

Job Summary

We are currently looking for a Senior Benefit Risk Evaluation Assessor – Musculoskeletal, Trauma and Cosmetic and a Senior Benefit Risk Evaluation Assessor-Cardiovascular and Fluid Management to join our Benefit/Risk Evaluation Team II Function within the Safety and Surveillance group.

These are full-time opportunities, on a 12 month fixed term contract/internal move or temporary promotion 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 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.

Job Description

Medicines and devices have traditionally been regulated separately largely driven by different regulatory processes and ways of working. As science and technology drives increasing understanding of disease, it is also opening new opportunities for treatments with both functions. Product profiles are changing, becoming ever more complex and the boundaries between functions are blurring. These changes provide a unique opportunity to bring functional 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 core objective of 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 and monitor signals across the product life cycle Evaluating the benefits and risks of medical products, safety signals, and developing effective and measurable risk mitigation measures Ensuring patients and other stakeholders are involved in the regulatory processes and appropriate messages are issued for patients and stakeholders following regulatory decisions 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 Benefit Risk groups I and II within Safety and Surveillance comprise 10 teams covering the following the therapeutic areas:

Benefit Risk I Benefit Risk II Oncology, Haematology, Thrombotic diseaseMusculoskeletal, Trauma and CosmeticImmunology, Biocompatibility and Non-ClinicalRespiratory, Imaging and Critical CareVaccines, Infectious Diseases and DiagnosticsCardiovascular and Fluid ManagementSenses, Movement and PainMetabolic and Renal SystemsNeuropsychiatric Disorders, Cognition and Mental HealthGastrointestinal System, Nutrition, Endocrine and Fertility

There is one 12 month fixed term vacancy (until July 2027) in the Musculoskeletal, Trauma and Cosmetic team and one 12 month fixed term vacancy (until August 2027) in the Cardiovascular and Fluid Management team. Both are to cover maternity leave.

The Musculoskeletal, Trauma and Cosmetic Benefit Risk Evaluation team monitors the safety of medicines and medical devices across these therapy areas. This includes a large focus on medical devices used for orthopaedics such as hip and knee joint replacements, cosmetic and plastic devices such as breast implants and wound care products used in the trauma context. The team cover medicines such as botulism toxin used for some cosmetic purposes, musculoskeletal gene therapy and creams and ointments used in wound care.

The Cardiovascular and Fluid Management Benefit Risk Evaluation team monitors the safety of medicines and medical devices used in the prevention and treatment and of cardiovascular disease. The team covers active and non-active cardiovascular implants, devices used externally as well as a wide range of medicines used for conditions such as ischaemic heart disease, heart rhythm disorders, heart failure as well as anticoagulants and medicines used for hypertension and lipid disorders.

What’s the role?

The core purpose of this role is to provide a robust benefit risk assessment of potential safety signals within the therapeutic areas using data from a range of sources and technical, scientific, clinical and regulatory knowledge and/or practical experience. Benefit risk assessors are responsible for engaging with a range of stakeholders including patients and the public to make timely and robust benefit-risk assessments and recommend safety actions and risk mitigations that are outcome focused.

The Benefit risk assessor will help deliver on our ongoing work and increase capacity to respond to new-emerging safety issues. They will have comprehensive medicine and/or medical device regulatory experience as well as professional, technical or scientific expertise in the relevant therapeutic areas.

The experience of the successful applicant will be vital in helping to support new members of the team build their competencies.

All benefit risk roles require working flexibly to perform and contribute to benefit risk assessments across all medical products as required.

Key Responsibilities:

Lead, influence or deliver consistently high-quality critical appraisals/assessment projects for significant safety or risk:benefit issues evaluating all relevant information sources including real-world evidence in accordance with agreed timelines, seeking expert advice where needed and ensuring the patient experience is duly considered Actively engage with patients and the public, key external stakeholders, government departments, professional bodies and the wider health sector Develop communications for the public, senior officials or ministers as required and provide scientific, technical and clinical input to ensure regular and timely advice is communicated to healthcare professionals Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals

Who are we looking for?

Our Successful Candidate Will:

Have comprehensive experience in critically analysing clinical/scientific information from a range of sources including case reports, registries, clinical trials/investigations, and observational studies, make sound judgements for recommendations to protect patient safety and public health. Have in depth knowledge of national and European/International medicine and/or medical device regulations and procedures aligned to the MHRA role in Benefit Risk Evaluation Have In depth knowledge of medical products in either the musculoskeletal, trauma and cosmetic or the cardiovascular and fluid management therapeutic area. Have excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise Share knowledge to improve the capability of the team, benefit risk evaluation group and the wider safety and surveillance function.

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Our Successful Candidate Will:

Have comprehensive experience in critically analysing clinical/scientific information from a range of sources including case reports, registries, clinical trials/investigations, and observational studies, make sound judgements for recommendations to protect patient safety and public health. Have in depth knowledge of national and European/International medicine and/or medical device regulations and procedures aligned to the MHRA role in Benefit Risk Evaluation Have In depth knowledge of medical products in either the musculoskeletal, trauma and cosmetic or the cardiovascular and fluid management therapeutic area. Have excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise Share knowledge to improve the capability of the team, benefit risk evaluation group and the wider safety and surveillance function.

Person specification

Method of assessment: A=Application, I=Interview

Behaviour Criteria:

Making Effective Decisions (A, I) Delivering at Pace (A, I) Communicating and Influencing (A, I) Working Together (A, I)

Experience Criteria:

Excellent written communication skills, including the ability to write authoritative reports. Excellent verbal and presentation skills (A, I,) Excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise. (A, I,) Comprehensive experience of relevant regulations and procedures applicable to medical devices. (A, I,) Previous therapeutic and/or technical knowledge and experience relevant to the work of the Benefit-Risk Evaluation teams listed above, and sharing knowledge to improve the capability of the team. (A, I) Comprehensive experience in critically analysing clinical/scientific information from a range of sources including case reports, registries, clinical trials/investigations, and observational studies, make sound judgements for recommendations to protect patient safety and public health. (A, I)

Technical Criteria:

A degree in a relevant health, scientific or engineering discipline e.g. medicine, biochemistry, physiology, medical engineering or regulation. (A) In depth knowledge of national and European/International medicine and/or medical device regulations and procedures aligned to the MHRA role in Benefit Risk Evaluation. (A, I) In depth knowledge of medical products in either the musculoskeletal, trauma and cosmetic or the cardiovascular and fluid management therapeutic area. (A, I) Previous experience of assessment focused work in breast and other cosmetic implants is highly advantageous for the post in the musculoskeletal, trauma and cosmetic team. (A, 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

Alongside your salary of £75,585, Medicines and Healthcare Products Regulatory Agency contributes £21,896 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 Motoring , Boundless by CSMA Variety of staff and Civil Service clubs On-going learning and development

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 (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

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: Previous therapeutic and/or technical knowledge and experience relevant to the work of the Benefit-Risk Evaluation teams covering musculoskeletal, trauma and cosmetic or cardiovascular and fluid management, and sharing knowledge to improve the capability of the team.

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: 02 June 2026

Shortlisting date: 08 June 2026

Interview date: 18-19 June 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

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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.

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 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, in the first instance, you should contact the MHRA Recruitment Team at careers@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.

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) (opens in a new window) 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 (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) 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 (opens in a new window).

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.

The Civil Service Code (opens in a new window) 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 (opens in a new window).

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 (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

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 : Becky Owen Email : Rebecca.owen@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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Skills

Benefit Risk Assessment
Stakeholder Engagement
Clinical Trials
Regulatory Knowledge
Data Analysis
Communication Skills
Team Leadership
Patient Safety
Scientific Expertise
Technical Knowledge
Interpersonal Skills
Project Management
Risk Mitigation
Public Health
Medical Devices
Therapeutic Areas