About the job

Job summary

The Musculoskeletal Trauma and Cosmetic Benefit Risk Evaluation team have a number of exciting opportunities to join their team. Are you a proactive, confident and enthusiastic person and want to join our group talented Benefit Risk Evaluation Assessors in Safety and Surveillance. The range of roles available require different levels of knowledge and experience. The ideal candidates will be willing to take on a challenge and be resilient.  

This is a full-time opportunity on a 12 month fixed term contract/internal move or temporary promotion basis (until February 2025) in the therapeutic area of Musculoskeletal Trauma and Cosmetic. There may also be opportunities to work on cross team and cross agency projects. 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 4 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 8 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.  

You will be part of multidisciplinary teams working on a range of safety issues involving medicines and medical devices and will be taking action to prevent risks leading to patient harm
In addition to the competitive salary and options for flexible hybrid working, all positions attract personal and professional development opportunities, we provide a minimum of 5 days training and development per year.

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 structure devices and medicines safety expertise with 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.

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 botox used for cosmetic purposes, musculoskeletal gene therapy and creams and ointments used in wound care.  

Job description

What’s the role? 

The purpose of the Benefit Risk Evaluation Assessor role is to undertake comprehensive assessments of medicines and medical devices throughout the product lifecycle to ensure that the benefits to patients are favourable and that any residual risks can be mitigated. Benefit risk evaluation Assessors work in partnership with a range of diverse stakeholders including patients and the public to ensure that medicines and medical devices are safe and effective for their intended purpose, working to communicate safety information where necessary to prevent potential harm to the end user 

The post holder will 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 evaluations of the balance of benefits and risks of medicinal products and medical devices in use in response to new data and make evidence-based recommendations for action to minimise risk and maximise benefit
•    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 
•    Develop and apply regulatory expertise on risk mitigation and risk management systems, supporting the agency’s objective of safely bringing innovative products to patients as rapidly as possible 
•    Be proactive in engaging with all stakeholders including patients and the public, health care professionals and companies to complete benefit risk evaluation assessments.

•    Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals.

Person specification

Who are we looking for? 

Our successful candidate will 

•    Have In depth knowledge and/or experience of relevant regulations and procedures applicable to medicines or medical devices and experience of sharing knowledge to improve the capability of the team, benefit risk evaluation group and the wider safety and surveillance function

•    Have experience of critically analysing complex clinical/scientific/technical information from several sources under pressure and making appropriate recommendations or decisions to protect patient safety/public health even when the evidence is not clear. 

•    Be able to use interpersonal skills to influence others to take safety seriously and develop and deliver critical improvements and improved ways of working across benefit risk evaluation, safety and surveillance and the wider Agency.

•    Have a degree/postgraduate qualification in a relevant discipline e.g. health, science, regulation or equivalent experience 

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 £70,011, Medicines and Healthcare Products Regulatory Agency contributes £18,902 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Things you need to know

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.
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

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:  26/01/2024

Interview date: W.C. 05/02/2024

 

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.

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 Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@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) (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.