Head of Adverse Incidents and Signal Analysis

We are currently looking for aHead of Adverse Incidents & Signal Analysisto join ourPatient Safety Monitoring Function within theSafety & Surveillance group.

Please note this opportunity is currently only available to those working within the Civil Service. Applications from nonCivil Servants may not be reviewed and may be rejected.

This is a fulltime opportunity on a permanentbasis. 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 signals across the product lifecycle the ability to evaluate the benefit/risk of signals of concern and design effective risk mitigations and a healthcare system able to implement them. The Safety and Surveillance Group brings together into a single integrated structure devices and medicines safety expertise with enforcement capabilities. These functions will be supported by our data and evidence generating capabilities complementing our signal generating capabilities produced via the Safety Connect System.

Medicines and devices have traditionally been regulated separately largely driven by different regulatory processes and ways of working but the consequence is a failure to capture on synergies and expertise and a duplication of effort in signal detection infrastructure data capture and communications. As science and technology drives increasing understanding of disease it also opens new opportunities for treatments with both medicines and devices. As a result product profiles are changing becoming ever more complex and the boundaries between medicines and devices are blurring. These changes provide a unique opportunity to bring medicines and devices capabilities together to better address the regulatory challenges of the future. Against this background and the drive to improve treatment availability for patients as early as possible safety remains at the heart of our decision making.

Whats the role

To lead the Adverse Incident & Signal Analysis team in the Vigilance Operations Team. The team is responsible for receipt classification and processing of all adverse incident reports responding to vigilance enquiries provision of incident data to stakeholders and vigilance signal detection evaluation and management to ensure product safety issues and risks to public health are identified and evaluated.

Key responsibilities:

• To lead the development of the Adverse Incident & Signal Analysis team to ensure continual operational delivery against key targets related to adverse incident reporting and signal detection; including the allocation of resources to effectively meet targets and fluctuating workload and maintaining and updating the quality management system for vigilance activities to reflect current business processes and systems.
• To identify and implement strategic solutions to meet changing business needs/focus including cross skilling of staff across incident handling and signal detection activities for all healthcare product types.
• To provide professional leadership to a multidisciplinary team to ensure continuing professional development of all staff in the team through the Vigilance Competency Framework and other accreditation programmes for career pathway development.
• Accountable for the provision of adverse incident data to all stakeholders including Expert Committees researchers and enquiries (e.g. (e.g. Press Parliamentary FOIs Lay and general enquiries) on routine vigilance incident & signal activities as well as emerging/high profile issues when required.
• To lead work programmes and projects within the Patient Safety Monitoring Function and represent the Agency externally.

Who are we looking for

Oursuccessful candidatewill:

• Proven ability of leading people and projects/investigations liaising with stakeholders to influence delivery of work.
• Ability to develop and deliver critical improvements and improved ways of working across specialist technical areas
• Making effective decisions Present reasonable conclusions from a wide range of complex and sometimes incomplete evidence. Make decisions confidently even when details are unclear or if they prove to be unpopular.
• Highly developed managerial skills a proven capable manager and demonstrable team leadership
• An understanding of the use of information systems and data standards involved in the reporting of adverse incidents and signal management Including ICSR R2 and R3 and IDMPto support business processes including sharing information externally with stakeholders.

If you would like to find out more about this fantastic opportunity please read our Job Description and Person Specification!

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The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

• Online application form including questions based on theBehaviour 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 theBehaviour 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 competencybased answers provided ensure you have read these thoroughly and allowsufficienttime. 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 as soon as possible.

Closing date:12^th May 2025

Shortlisting date: from 13^th May 2025

Interview date:from 19^th May 2025

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 questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

Successful candidates must pass a disclosure and barring security check as well as animal rights and prolife activism checks. People working with government assets must completebasic personnel security standard checks.

Applicants who are successful at interview will be as part of preemployment 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 applicants 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 TaxFree Childcare. Determine your eligibilityhere.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit 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 Florentina OleylamiHead of Talent Acquisition.

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ