Deputy Director Benefit Risk Evaluation II - £76,000 to £86,000 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency
Apply before 11:55 pm on Monday 25th November 2024
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About the job
Job summary
We are currently looking for a Deputy Director Benefit Risk Evaluation II to join our Benefit Risk Evaluation 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, 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 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.
To deliver effectively on our central mission of protecting public health, we need robust vigilance processes that are able to quickly detect, monitor and evaluate safety signals across the product lifecycle, the ability to critically evaluate the benefit/risk balance of signals of concern and design effective risk mitigations, to communicate effectively to patients and the public and a healthcare system able to implement them. 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.
Job description
In support of the mission of the Safety & Surveillance group, there are two Benefit Risk Evaluation functions – each comprised of c40 highly skilled staff, working across five specialist teams – which make judgements on continued benefit vs risk and risk mitigation strategies for medicines and devices. The Benefit Risk Evaluation II function covers healthcare products relating to musculoskeletal, trauma, cosmetic, respiratory, imaging, cardiovascular disease, metabolic and renal and gastrointestinal, endocrine and fertility. These teams critically analyse information from a wide range of sources to reach decisions on the benefit risk balance of medical products and appropriate approaches to mitigate any risks. Such assessments typically involve analysis of spontaneous adverse reports, the published literature, non-clinical and clinical data from the companies, lived experience from patients and may require bespoke epidemiological studies. As the DD of BRE II you will be responsible for overseeing these assessments across diverse therapeutic areas and products, continuing exploring how we can improve our processes and data sources and supporting the strategic direction of both the Safety and Surveillance group and that of the wider Agency.
This role will suit an experienced clinician, academic or regulatory specialist with an interest in protecting patient safety. The individual will provide both operational and strategic leadership of a team of approximately 40 specialist staff who are primarily responsible for the Agency’s medicine and device vigilance benefit-risk evaluations. We are looking for an innovative leader to drive new regulatory thinking to deliver better on the safety of medical products.
The Agency is facing a rapidly evolving external environment involving increasingly complex products and utilisation of these products across an ever more diverse health system. The post holder will be charged with targeting activity effectively and ensuring that the Agency has the technical and managerial skills in place to reflect an increasingly visible sector and more sophisticated popular understanding of medicines and devices.
The post holder will be responsible for continuing to build expertise and assessment capabilities across BRE II as medical products evolve, maximising opportunities arising from the combination of devices and medicines expertise, building efficient processes to deliver quality assessments in order to deliver effective benefit risk evaluation, continual improvement processes to capitalise on new analytical methodologies and data sources and ensuring the development of all staff within the function. The post holder will also ensure processes are in place to manage resourcing for relevant activities across the Agency and product life cycle.
The post holder will work with patients and the public as well as strategic partners in the clinical and academic community to utilise and influence all additional sources of safety information available (such as registries) and develop and maintain relationships with other regulators in the EU and beyond as part of a systematic approach to medical product safety.
The post holder will take a lead in working with Department of Health & Social Care, NHS, professional bodies, EU and international partners and industry to achieve safer and more effective use of medicines and medical devices and will also contribute to the corporate management of the Agency through contributions to cross-Agency projects, external initiatives as well as deputising for the Chief Officer where necessary.
Key Responsibilities:
- Provide professional leadership to a wide range of staff (including scientists, clinicians, and regulatory specialists), motivating and ensuring their continuing development ensuring they have clear leadership and deliver performance which meets the objectives and targets of the Agency;
- Develop and drive the strategic direction and priorities of the function and, as a key member of the Senior Leadership Team and wider One Agency Leadership community, facilitate delivery of overarching Agency strategies, working in partnership with other Groups to deliver cross cutting initiatives;
- Ensure a consistent high quality of our comprehensive risk benefit assessments and resultant risk mitigation decisions across the vigilance units; lead the design and implementation of new safety measures across the health care ecosystem; and co-ordinate horizon scanning inc. supporting innovators, anticipating and responding to future regulatory challenges and, where necessary, developing grant proposals for external funding;
- Actively engender a regulatory environment that supports safer medical product regulation and, by doing so, ensure it is balanced, proportionate, of high quality and that safe innovation is supported, making key decisions within the bounds of legislation but with discretion in developing interpretations;
- Build credible working relationships with a range of external stakeholders – including the Department of Health and Social Care (DHSC), NHS, medical Royal Colleges, specialist societies and associations, academia as well as the MHRA’s advisory committee structure - exerting balanced judgement and influence to enhance the Agency’s ability to deliver objectives in a networked environment where patient safety is a shared responsibility;
- Lead on the implementation of effective collaboration with EU and international partners around important safety signals for both medicines and devices;
- Provide timely, up-to-date, and relevant information on the safety and performance of medicines and medical devices to Ministers, DHSC, relevant partners in the health landscape including the wider NHS, users and manufacturers;
- Oversee safety publications; liaise with press office, DHSC, and wider stakeholders on all safety related media activity; and proactively contribute to the Agency’s plans to continuously improve patient and public involvement in its work across all parts of the regulatory journey.
Person specification
- A strong and inclusive corporate and leader, experience in the management of professionally qualified staff, confident in both people leadership and policy development in an operational context, with the gravitas to earn the respect of stakeholders.
- Highly developed interpersonal and influencing skills, and the credibility and ability to build excellent relationships and networks with key stakeholders across organisational boundaries.
- Knowledge and understanding of working in a regulatory environment would be an advantage but is not essential.
- Medical or scientific degree in a relevant discipline, e.g. life sciences, medical engineering, toxicology, medical physics, biomaterials or healthcare professional qualification or equivalent qualifications or relevant work experience.
- Extensive knowledge or academic specialisation in one or more areas related to clinical, academic, medical engineering and/or pharmaceutical medicine.
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 a statement of suitability, which you will need to answer in the question section. Your answer should be no more than 2 A4 pages of Arial 11 pt and no more than 6000 characters demonstrating how you meet the person specification. 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. Please ensure not to include any personal identifying information on your supporting information.
- 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 statement of suitability provided. You can view the criteria 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: 25th November 2024
Shortlisting date: from 26th November 2024
Interview date: 6th December 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
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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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Contact point for applicants
Job contact :
- Name : The Resourcing Team
- Email : careers@mhra.gov.uk
Recruitment team
- Email : Careers@mhra.gov.uk
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