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

We are currently looking for a Vigilance Improvement Lead to join our Patient Safety Monitoring Function within the Safety & Surveillance 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 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 new 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 new 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 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?
To lead the maintenance and development of the MHRA vigilance system 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 improvement, + 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 our 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, 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.
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., + 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.

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).

+ Proven highly effective organisational and time management skills with a flexible attitude to work and demonstrated ability to deliver multiple tasks to deadlines whilst maintaining high standards of quality.
+ Project management experience, with financial awareness of relevant finance rules and requirements, working with external partners within the vigilance environment
+ 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., Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.

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
+ 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