Head of Vigilance Operations
Head of Vigilance Operations
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Job Description
We are currently looking for a Head of Vigilance Operations to join ourPatient Safety Monitoring Function within theSafety & 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. 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 safety remains at the heart of our decision making.
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
Whats the role
The post holder will be accountable for the operational delivery of the Signal Analysis Unit Defective Medicines Report Centre and Biobank team including Agency targets and business planning.
The post holder is required to provide both operational and strategic leadership of a team of staff c50 FTE including pharmacists scientists and medical device experts who are responsible for managing end to end Yellow Card processes from incident processing to signal detection & initial assessment management & investigation of defective medicine reports and managing & responding to vigilance enquiries and data requests.
The post holder will lead delivery of large-scale projects of digital transformation and continuous development of our vigilance activities as well as multi-stakeholder initiatives with budget holder responsibilities and delegated financial authorisation for the Patient Safety Monitoring Function and project cost centres.
Key responsibilities:
Accountable for delivery of the operational objectives of the Yellow Card Operational Teams including Yellow Card data collection signal detection activities and investigation of defective medicine reports and responsible for maintaining the quality management system for vigilance activities.
Work alongside senior managers in the Patient Safety Function to deliver the strategic direction of the function to maximise the potential of the Yellow Card scheme & our vigilance activities both in terms of the UK healthcare system and internationally.
Lead large-scale multi-stakeholder initiatives with responsibility for project budgets resources and delivery of outputs.
Lead on the development of Agency and Functions IT systems to ensure vigilance systems meet the future needs of medicines and medical devices.
Accountable for delivery of Agency performance measures and a high level of service to internal and external stakeholders including FOI requests and Press and Parliamentary enquiries with timely provision of information to build trust and demonstrate transparency.
Who are we looking for
Oursuccessful candidatewill have:
Leadership experience to manage professionally qualified staff and the gravitas to earn the respect of stakeholders
Extensive experience working in incident and signal management processes
Experience of working in large scale multistakeholder IT projects to ensure collaborative working and delivery
Extensive knowledge of spontaneous reporting/vigilance systems to deliver continuous improvement with proven successful delivery
Extensive experience of working with international projects and with other international regulators to ensure collaborative working and delivery.
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 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
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:28 July 2025
Shortlisting date: 29 July 2025
Interview date:13 August 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 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.
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 Oyelami Head 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
Required Experience:
Director
Employment Type
Full-Time
