Vigilance Improvement Lead - £44,825 p.a. + benefits

Medicines and Healthcare products Regulatory Agency; London; Hybrid; GBP 44,000 - 52,000; Full time

Job summary

Join the Medicines and Healthcare products Regulatory Agency as a Vigilance Improvement Lead. This pivotal role in the Patient Safety & Monitoring Team involves managing and enhancing vigilance systems to protect public health. You will be instrumental in improving incident handling and implementing innovative solutions to ensure safety in medicines and medical devices. The position is a full-time, fixed-term contract until July 2027, based in Canary Wharf, London.

Benefits

Annual leave of 25 days, rising to 30 days

Occupational sick pay

Flexible working options

Civil Service pension scheme

Qualifications

• A degree or equivalent qualification in a relevant discipline.
• Strong understanding of information systems in ADR reporting and signal management.
• Experience in health-related systems, project management experience.

Responsibilities

• Manage day-to-day oversight of internal vigilance systems.
• Lead process improvements for adverse incident handling.
• Project management of vigilance development work.

Skills

Project Management

Analytical Skills

Communication

Education

Degree in pharmacy, science, engineering or related field

Job description

Vigilance Improvement Lead - £44,825 p.a. + benefits

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Vigilance Improvement Lead - £44,825 p.a. + benefits

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Job Summary

We are currently looking for a

Canary Wharf, London

Job Summary

We are currently looking for a Vigilance Improvement Lead to join our Patient Safety & Monitoring Team within the Safety & Surveillance group. There are two positions available.

This is a full-time opportunity, on a fixed term contract/internal move or temporary promotion basis until July 2027. 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.

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.

Job Description

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 is also opening 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
  
  

The Patient Safety Monitoring Function is responsible for developing and delivering a world class vigilance system to detect and monitor safety signals for medicines, medical devices, vaccines and blood products.

What’s the role?

The successful candidate will lead the maintenance and development of the MHRA vigilance systems to ensure continuous improvement in our adverse incident handling and signal management processes. The post holder will lead on development of our internal vigilance system technical components, including our case management system and system interfaces, to ensure high level service delivery for business users for all medicinal product types. The role will assist in developing innovative and strategic approaches to process improvements and solving vigilance issues using technology and support the development and management of vigilance data sources and taxonomies.

The role will also be responsible for project management of vigilance development work within the Team and assist with ensuring complex multi-stranded development projects, and areas of priority work, are delivered on time and within budget.

Key Responsibilities:

• Manage the day-to-day oversight and maintenance of internal vigilance systems including identification and logging of system issues requiring technical resolution.
• Lead on identifying and developing improved approaches to processes and IT systems, understanding and analysing user and business needs to enable continuous improvement for our adverse incident handling and signal management processes.
• Coordinate system testing for technical fixes and enhancements for our vigilance systems working with business colleagues, IT and external suppliers.
• Lead on development and delivery of training and learning packages for staff and new joiners on vigilance system enhancements and new business processes.
• Project management including project planning, tracking of progress, and reviewing processes for vigilance projects, liaising with other colleagues and external stakeholders.
• Plan and conduct stakeholder engagement activities with close liaison with a wide range of stakeholders to ensure vigilance systems meet the needs of external stakeholders, including patients & the public.
  
  

Key Responsibilities:

• Manage the day-to-day oversight and maintenance of internal vigilance systems including identification and logging of system issues requiring technical resolution.
• Lead on identifying and developing improved approaches to processes and IT systems, understanding and analysing user and business needs to enable continuous improvement for our adverse incident handling and signal management processes.
• Coordinate system testing for technical fixes and enhancements for our vigilance systems working with business colleagues, IT and external suppliers.
• Lead on development and delivery of training and learning packages for staff and new joiners on vigilance system enhancements and new business processes.
• Project management including project planning, tracking of progress, and reviewing processes for vigilance projects, liaising with other colleagues and external stakeholders.
• Plan and conduct stakeholder engagement activities with close liaison with a wide range of stakeholders to ensure vigilance systems meet the needs of external stakeholders, including patients & the public.
  
  

Person specification

Who are we looking for?

Our Successful Candidate Will Have:

• A 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 strong understanding of the use of information systems involved in the reporting of ADRs and signal management to support business processes including sharing knowledge externally with stakeholders.
• Experience in supporting delivery of technical improvements to systems. Specifically experience with health related systems, including pharmacovigilance, device incidents or electronic healthcare record systems desirable but not essential. Coding experience not required.
• Project management experience, with financial awareness of relevant finance rules and requirements, working with external partners within the vigilance environment.
  
  

If you would like to find out more about this fantastic opportunity, please read our Job Description 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 [e-mail]

Alongside your salary of £44,825, Medicines and Healthcare Products Regulatory Agency contributes £12,985 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
  
  

Selection process details

The Selection Process:

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.
• 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: experience in supporting delivery of technical improvements to systems. Specifically experience with health related systems, including pharmacovigilance, device incidents or electronic healthcare record systems desirable but not essential. Coding experience not required.

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 allow sufficient time. 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 [e-mail] as soon as possible.

Closing date: 3rd July 2025

Shortlisting date: From 4th July 2025

Interview date: w/c 14 July 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 questions, please contact [e-mail]

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.

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.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact [e-mail].

In accordance with the Civil Service Commissioners’ 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 Florentina Oyelami, Head of Talent Acquisition, [e-mail].

If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk

[e-mail]

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.

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.

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.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

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 : Kendal Harrison
• Email : [e-mail]
  
  

Recruitment team

• Email : [e-mail]
  
  

Further information

In accordance with the Civil Service Commissioners’ 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 [e-mail], 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 - [e-mail] - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Administrative

• Industries

  Government Administration

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