Benefit Risk Medical Assessor - £76,000 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency
Apply before 11:55 pm on Sunday 6th October 2024
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About the job
Job summary
We are currently looking for a Benefit Risk Medical Assessor to join our Benefit-Risk Evaluation I Function within the Safety and Surveillance group.
This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, London. Please note that this role can only be worked in the UK and not overseas.
Government departments/agencies are working towards implementing a minimum 60% attendance in office sites.
We are implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable 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, 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 delivered via the common vigilance platform SafetyConnect.
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.
The Benefit Risk groups I and II within Safety and Surveillance and comprise of 10 therapeutic area multidisciplinary teams. The Vaccines, Infectious Diseases and Diagnostics team (TAU3) monitors the safety and effectiveness of medicines and medical devices used for the detection, management and prophylaxis of infectious diseases. The team therefore monitors and covers the post-market surveillance and risk assessment of:
- Vaccines for the prevention of infectious disease such as influenza, RSV and COVID-19, vaccines for childhood diseases, and travel/occupational vaccines.
- Medicines indicated for the treatment of infectious disease such as antibacterials, antifungals, and antivirals.
- All in vitro diagnostic devices.
- Protective medical equipment.
Job description
Reporting to the Head of Vaccines, Infectious Diseases and Diagnostics a Benefit Risk Medical Assessor is required to conduct assessment of a wide range of data, contributing to the Agency’s wider vigilance activities and ensuring that safe and effective medicines and medical devices continue to be available to UK patients.
- Analyse evidence from a range of sources as well as taking into account stakeholders and patients’ views to monitor the benefit and risk balance of medicinal products and devices in clinical use.
- Undertake effective matrix working as appropriate across the Benefit-Risk Evaluation functions, the wider Safety and Surveillance Group and Agency life-cycle Groups.
- Ensure that scientific, technical, and clinical benefit-risk assessment of potential safety issues takes place promptly and contributes to sound regulatory decisions regarding safety of medicines and devices.
Key responsibilities:
Assessment of Safety Data
- Proactively monitor the safety of personally allocated products, including innovative medicines and medical devices.
- Conduct assessments of the balance of benefits and risks of medicines and medical devices in response to new data, including working with less experienced colleagues and across teams as required, act as the lead assessor, or advising assessor (as appropriate)
Sharing Knowledge and Development of Self and Colleagues
- Provide a leadership role by mentoring or coaching other assessors to enhance their knowledge and contribution in the wider sharing of knowledge
Contribution to Policy and Procedures including communication with Stakeholders
- Alongside experts and managers, initiate, lead or influence guidelines, procedures or policy and practice nationally or otherwise that are beneficial for protection of public health
Person specification
Our successful candidate will:
Behaviours
- Ability to demonstrate “making effective decisions”, “delivering at pace”, “communicating and influencing” and “working together”.
Experience
- Excellent written communication skills, including the ability to write authoritative reports. Excellent verbal and presentation skills
- Excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise.
- Sound knowledge and understanding of the relevant regulatory procedures
Technical
- Medically qualified and registered to practice with the General Medical Council
- Clinical, academic or pharmaceutical medicine experience, including evidence of an up-to-date specialist level of knowledge and evidence of analysis of data and preparation of reports, scientific publications or reviews or manuscripts for regulatory submissions.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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Benefits
- 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
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.
- 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.
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 careers@mhra.gov.uk as soon as possible.
Closing date: 6th October 2024
Shortlisting date: from 7th October 2024
Interview date: week commencing 21st October 2024
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.
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
Civil Service Commission
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Feedback will only be provided if you attend an interview or assessment.
As part of accepting this role you will be agreeing to the expected assignment duration set out above. This will not result in a contractual change to your terms and conditions. Please note this is an expectation only, it is not something which is written into your terms and conditions or indeed which the employing organisation or you are bound by. It will depend on your personal circumstances at a particular time and business needs, for example, would not preclude any absence like family friendly leave. It is nonetheless an important expectation, which is why we ask you to confirm you agree to the assignment duration set out above.
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Working for the Civil Service
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).
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Contact point for applicants
Job contact :
- Name : The Resourcing Team
- Email : careers@mhra.gov.uk
Recruitment team
- Email : Careers@mhra.gov.uk
Further information
