Head of Safety Surveillance Analytics and Data (Medicines and Devices) - £75,585 p.a. + benefits

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.

In support of this mission, the Scientific Data & Insight function is responsible for developing expertise in house to deliver evidence to underpin these new approaches. Quality and speed of regulatory decision making is dependent on having access to high-quality, representative data in a timely fashion but also being able to access and analyse in-house data and information in the most effective way. A critical aspect of this work will include the exploration and application of new analytical methodologies including AI and machine learning methods such as natural language processing, large language models and computer modelling and simulation approaches. Hence developing and strengthening capacity and capability in data science within MHRA is a key strategic objective to ensure we are best placed to address the future evidence generation needs for both medicines and devices., The Safety Surveillance Data and Analytics (Medicines and Devices) (SSDA) team is a central analysis team within the Safety and Surveillance function. Its purpose is to develop novel analytical approaches to support and modernise safety monitoring of medicines and medical devices.

The primary purpose of the role is to lead, develop and manage the performance of the team ensuring that the team runs efficiently and effectively. Alongside this the post holder will collaborate with colleagues across the Agency to develop a comprehensive market surveillance system underpinned by fit-for-purpose integrated software to ensure the safe and effective use of state of the art technologies to improve safety and surveillance of medical products., * Provide effective leadership and management to the SSDA team, to develop staff in line with the Agency’s people strategies and build an inclusive culture of high and continuous performance.

• Line-manage G7-team leaders.
• Provide scientific and thought leadership to the team.
• Act as an agency-wide expert in medical devices and data science.
• Ensuring our systems meets the patient safety and vigilance needs for all safety report types for devices, including user reports and all types of medical device manufacturer market surveillance reports.
• Build and maintain effective partnerships with external stakeholders to ensure effective and appropriate mechanisms for medical data sharing.
• Work cross-Agency to develop device and data capability and capacity for operational services, business intelligence, and safety signal detection to meet the needs for future medical device regulation and wider Agency market surveillance.
• Lead MHRA participation in national and international partnership work on device safety related market surveillance developments and data-science including reporting forms, terminology development, and other new and novel market surveillance methods.
• Ensure effective evidence generation across the product life cycle and contribute proactively to patient and public involvement activities, ensuring these viewpoints inform our approach to data capture and sharing.
• Coordinate horizon scanning on innovation and developing capacity to support innovators and anticipate future regulatory challenges.
• Engage in and lead research to improve the agency’s ability to monitor medical device safety.
• Develop novel approaches to device safety monitoring.
• Lead the scientific publication activities of the team.
• Ensure the function maintains a sustainable operating model and actively seek new opportunities for growth e.g. by supporting the Deputy Director to develop grant proposals.
• Contribute to cross- agency activities such as supporting innovation, advice-giving and other activities to be identified including developing and agreeing suitable resourcing plans., 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.
• Online application form, including a statement of suitability, attached as a PDF of no more than 1000 words 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.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of Leadership.

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., 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., * 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)
• 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

Do you have experience in Presentation skills?, Do you have a Doctoral degree?, We are looking for a person with rich experience in people leadership. While not a condition of appointment existing badging (GORS or GSS) would be an advantage., * Experience in the management and/or supervision of professional staff.

• Membership in GORS or GSS is desirable.
• Extensive knowledge of the medical devices or demonstrated willingness to acquire this knowledge.
• Extensive knowledge in data-science, machine learning and simulation methods.
• Doctoral degree in a numerate discipline e.g. science, engineering or epidemiology, or equivalent experience developed through previous roles.
• Understanding of or interest in the medical device regulatory landscape.
• Strong understanding of data analysis methods, and statistics.
• Understanding of device epidemiology (desirable)

Behaviours to be assessed.

• Leadership (Lead Behaviour)- Promote diversity, inclusion and equality of opportunity, respecting difference and external experience. Welcome and respond to views and challenges from others, despite any conflicting pressures to ignore or give in to them. Stand by, promote or defend own and team’s actions and decisions where needed. Seek out shared interests beyond own area of responsibility, understanding the extent of the impact actions have on the organisation. Inspire and motivate teams to be fully engaged in their work and dedicated to their role.

* Communicating and Influencing - Communicate with others in a clear, honest and enthusiastic way in order to build trust. Explain complex issues in a way that is easy to understand. Take into account people’s individual needs. Deliver difficult messages with clarity and sensitivity, being persuasive when required. Consider the impact of the language used. Remain open-minded and impartial in discussions, whilst respecting the diverse interests and opinions of others. Introduce different methods for communication, including making the most of digital resources whilst getting value for money. Monitor the effectiveness of own and team communications and take action to improve where necessary., Doctoral degree in a numerate discipline e.g. science, engineering or epidemiology, or equivalent experience developed through previous roles, * Leadership

• Communicating and Influencing
• Changing and Improving, 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., Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Pulled from the full job description

• Pay rise
• Childcare
• Annual leave
• Sick pay
• Company pension
• Season ticket loan, 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