Head of Vigilance Development

We are currently looking for a Head of Vigilance Development to join ourPatient Safety MonitoringFunction within the Safety & Surveillance group.

This is a full-timeopportunity on a permanent basis. The role will be based in 10 South Colonnade Canary Wharf London E14 4PU.

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 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.

As such the central mission of the Safety & Surveillance portfolio is to protect the public from risks associated with medicines and medical devices by:

• Ensuring a world class comprehensive vigilance system that can promptly detect and monitor signals across the product life cycle

• Evaluating the benefit risk of signals and developing effective and measurable risk mitigation measures

• Deploying innovative interventions to reduce the criminal threat

• Exploiting data and embracing new technologies to develop the evidence to support our actions and understand their impact

The Patient Safety Monitoring Functionis responsible fordeveloping and delivering a world class vigilance system to detect andmonitorsafety signals for medicines medical devicesvaccinesand blood products.

Whats the role

The post holder will lead development of the MHRA vigilance systemincluding vigilance system transformation workto ensure continuous improvement of joined-up systems and processes for all medicinal product types. Accountable for key projects within the Patient Safety Monitoring Function and engagement with strategic stakeholders in the UK healthcare system for adverse incident data collection and signal management processes.

This role leads delivery of continuous vigilance systems improvements to support collection and assessment of reaction and adverse incidents. Systems under the roles responsibility include the public facing Yellow Card scheme as well as industry reporting portals such as reporting for pharmaceutical companies devicemanufacturersand blood incidents.

The mainobjectivesare to work across the Agency and Health network to ensure MHRA has the information necessary to assess potential harms from medicinal products and takeappropriate regulatoryaction as swiftly as possible.

Key responsibilities:

• Lead the development and enhancement of Safety & Surveillance IT systems and processes for the Patient Safety Monitoring Function to ensure continual improvement and best use of available resources for adverse incident data management and signal managementactivities ensuring the qualitymanagement system for vigilance activities is updated in line with new and incoming procedurestechnologiesand legislation.

• Collaborate and build relationships across the Agency and the UK Health Family to ensure vigilance systems are integrated withappropriate datasets datastandardsand terminologies.

• Accountable forsetting strategic direction and leading delivery ofkey projects arising from Yellow Card strategy recommendations and stakeholderengagementas directed by the Senior Leadership Group.

• Represent the Agency at stakeholder working groups to develop best practicerecommendations and foster new alliances for adverse incident data collection and other vigilance activities.

Who are we looking for

Oursuccessful candidatewill have the following:

Experience

• Extensiveexperience of successfully managing and usinglarge quantitiesof adverse incident data for evaluation and reporting providing information on complex and technical matters.

Behaviours

• Leadership- Welcome and respond to views and challenges from others despite any conflicting pressures to ignore or give in to them. Stand bypromoteor defend own and teams 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 to create a culture of high performance and continuous improvement.

• Seeing the Big Picture- Ensure plans and activities in your area of work reflect wider Agency and government strategic priorities and communicate effectively with senior leaders to influence future strategies. Bring together viewsperspectivesand diverse needs of stakeholders to gain a broader understanding of the issues surrounding policies and activities.

Technical

• Detailed knowledge of the data standards taxonomies and systems involved in the reporting and management of adverse incidents for the maintenance and performance of business processes within Patient Safety Monitoring.

• Strong knowledge and understanding of medicines and medical device regulationfor post marketing surveillance.

Person Specification:

Method of assessment:AApplication IInterview

Behaviour Criteria:

• Seeing the Big Picture(A I)

• Leadership(A I)

• Communicating and Influencing(A I)

Experience Criteria:

• Extensive experience of successfully managing and using large quantities of adverse incident data for evaluation and reporting providing information on complex and technical matters. (A I)

• Project management experience demonstration of successful delivery of projects to agreed timescales and budgets with deliverables of high quality (A I)

• Knowledge of both medicines and medical devices legislative landscape and associated data standards and terminologies (A I)

• Extensive experience of working with international projects and with other international regulators to ensure collaborative working and delivery. (A I)

• Experience working with innovative technologies to delivery benefits to vigilance systems(A I)

Technical Criteria:

• Degree or equivalent qualification in a relevant discipline e.g. pharmacy science medical engineering medical physics biomaterials or healthcare professional qualification or equivalent qualifications or relevant work experience. (A)

• Detailed knowledge of the data standards taxonomies and systems involved in the reporting and management of adverse incidents for the maintenance and performance of business processes within Patient Safety Monitoring. (A)

• Effective presentation and communication skills including excellent writing skills for preparing and independently writing briefing / formal reports. (A)

• Strong knowledge and understanding of medicines and medical device regulation.(A)

Strengths Criteria

• Improver(I)

• Disciplined(I)

• Adaptable(I)

• Team Leader (I)

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.

• 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 competency-based 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

Artificial Intelligence can be a useful tool to support your application however all examples and statements provided must be truthful factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others or generated by artificial intelligence as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see ourcandidate guidancefor more information on appropriate and inappropriate use.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:19 February 2026

Shortlisting date: From 20 February 2026

Interview date:w/c 16 March 2026

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 pro-life activism checks. People working with government assets must completebasic personnel security standard checks.

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 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 Tax-Free Childcare. Determine your eligibilityhere.

Standard Cabinet Office rules on pay will apply to civil servants appointed on level transfer or promotion. Their salary will increase to the minimum of the SCS PB1 range or by a promotion award of up to 10% more than their current basic salary excluding all allowances (whichever is the greater).

Individuals appointed on level transfer will retain their existing basic salary excluding all allowances. You may be eligible for a non-consolidated annual bonus payment subject to successful performance in line with the Senior Civil Service pay arrangements. These are set annually within the guidelines laid down by the Cabinet Office.

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

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