Benefit Risk Evaluation Assessor - £44,825 p.a. + benefits

Medicines and Healthcare products Regulatory Agency; London; Hybrid; GBP 45,000; Full time

Job summary

The Medicines and Healthcare products Regulatory Agency is seeking two Benefit Risk Evaluation Assessors to conduct thorough assessments of safety signals related to medicinal products. This full-time position involves engaging stakeholders and developing impactful safety messages, supporting critical health safety initiatives in London.

Benefits

Civil Service Defined Benefit Pension Scheme

Annual Leave: 25 days rising to 30 days

Flexible working

Interest free season ticket loan or bike loan

Employee Assistance Services

Qualifications

• Demonstrate understanding of complex project management.
• Experience with benefit risk evaluations in medical devices or medicines.
• Proficient in communicating and influencing stakeholders effectively.

Responsibilities

• Conduct assessments regarding medical and medicinal products.
• Engage proactively with stakeholders to complete evaluations.
• Recommend regulatory actions to enhance benefits and mitigate risks.

Skills

Communicating and Influencing

Making Effective Decisions

Proven understanding of risk management principles

Managing complex projects

Benefit risk evaluations

Job description

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Job Summary

We are currently looking for 2

London

Job Summary

We are currently looking for 2 Benefit Risk Evaluation Assessors to join our Benefit Risk Evaluation II and I Function within the Safety & Surveillance group. The posts are in the Gastrointestinal system, nutrition, endocrine unit & fertility and Skin, senses, movement and pain unit.

These are full-time opportunities, on a permanent basis. The roles will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that these roles 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 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

The core purpose of these roles is to provide a robust benefit risk assessment of potential safety signals 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.

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
  
  

General

• Contribute to external committees and groups as appropriate to raise standards in devices and medicinal products safety
• Be committed to continuous development to acquire and maintain knowledge and skills
  
  

The core purpose of these roles is to provide a robust benefit risk assessment of potential safety signals 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.

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
  
  

General

• Contribute to external committees and groups as appropriate to raise standards in devices and medicinal products safety
• Be committed to continuous development to acquire and maintain knowledge and skills
  
  

Person specification

Our Successful Candidates Will Demonstrate The Following:

• Communicating and Influencing
• Making Effective Decisions
• Proven understanding of risk management principles to reduce harm and promote effective use of medical products. Technical knowledge and/or practical experience of a range of medical devices and/or medicines
• Proven experience of managing complex projects to agreed milestones and managing conflicting priorities
• Proven experience in conducting benefit risk evaluations of medical devices and or medicines is highly advantageous
  
  

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 [e-mail]

Alongside your salary of £44,825, Medicines and Healthcare Products Regulatory Agency contributes £12,985 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
  
  

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 having previous relevant experience such as healthcare, medical device or medicinal product industry or regulatory environment.

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.

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 [e-mail] as soon as possible.

Closing date: 20th June 2025

Shortlisting date: from 23rd June 2025

Interview date: from 30th June 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 questions, please contact [e-mail]

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.

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 [e-mail].

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 Oleylami, Head of Talent Acquisition, [e-mail].

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

[e-mail]

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 : Catriona Blake
• Email : [e-mail]
  
  

Recruitment team

• Email : [e-mail]
  
  

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 [e-mail], 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 - [e-mail] - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Government Administration

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