Job Description

Details

Reference number

329715

Salary

\xc2\xa370,011

A Civil Service Pension with an average employer contribution of 27%

Job grade

Grade 6

Contract type

Permanent

Business area

MHRA - Safety and Surveillance Group

Type of role

Science

Working pattern

Full-time

Number of jobs available

1


Contents

• Location About the job Benefits Things you need to know Apply and further information

Location

London
About the job

Job summary

We are currently looking for a Head of Device Data Management to join our Scientific Data and Insight team within the Safety and Surveillance Group 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 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. 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 main aim of the group is 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\xe2\x80\x99s 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 will be 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. In the future this will include the 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.

Job description

What\xe2\x80\x99s the role? The Agency is in the process of developing a new medical device regulatory regime for the GB/UK market together with an underpinning medical device regulatory management IT system which will incorporate a new medical device registration system capturing important master/reference data on:

• regulatory actors (manufacturers, UK representative persons etc.).
• all medical devices placed on the UK market under the new regime and linking intelligently into SafetyConnect and other MHRA regulatory management systems.

In addition, in order to develop a comprehensive post-market surveillance system for devices which can capture long term health outcomes, the postholder will work with external partners and stakeholders to build new data capabilities. 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 medical devices. The Head of Device Data Management will develop, lead, and manage the performance of the team within the Scientific Data and Insight function to ensure the Agency designs and uses its safety, regulatory and master/reference data to protect patient safety and public health effectively and efficiently. The post holder will need work strategically with partners and stakeholders, both nationally and internationally, delivering thought leadership to drive continual improvement in evidence generation for medical device post-market safety surveillance in the UK and globally.
Key responsibilities:

• Develop and lead the implementation of a strategy to ensure that the agency acquires and optimally integrates and processes the data necessary to operate a successful UK and GB medical device regulatory system, as it is developed and established.
• Provide effective leadership and management to the Device Data Management team, to develop staff in line with the Agency\xe2\x80\x99s people and HR strategies and build and inclusive culture of high and continuous performance.

• 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.
• Support effective partnerships with external stakeholders to ensure that MHRA provides the necessary master data from its medical device registration system to the medical device information system (MDIS) and acquire and effectively process the necessary medical device performance data from MDIS and its associated medical device registries.

Person specification

Who are we looking for?
Our successful candidate will:

• Experience of complex policy development or project management related to information systems involving diverse stakeholders.
• Experience communicating complex messages to stakeholders across multiple disciplines and professional backgrounds.
• Experience in the management and/or supervision of professional staff
• Strong understanding of the medical product regulatory landscape
• Strong understanding of information systems and data management

If you would like to find out more about this fantastic opportunity, please read our 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 \xc2\xa370,011, Medicines and Healthcare Products Regulatory Agency contributes \xc2\xa318,902 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

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, attached as a PDF of no more than 750 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.

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.
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: 22/12/2023 Interview date: w/c 15/1/2024
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\xe2\x80\x99s 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\xe2\x80\x99 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.
Apply and further information

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 :
  The Resourcing Team
  Email :
  Careers@mhra.gov.uk

Recruitment team

• 
  Email :
  Careers@mhra.gov.uk

Further information

In accordance with the Civil Service Commissioners\xe2\x80\x99 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 Careers@mhra.gov.uk, 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 - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ