JOB SUMMARY

We are currently looking for a Vigilance Collaborations Specialist to join our Patient Safety Monitoring Function within the Safety and Surveillance group.
This is a full-time opportunity, on a 1 year fixed term contract/internal move or temporary promotion 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.

JOB DESCRIPTION

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.

WHO ARE WE LOOKING FOR?

Our successful candidate will have:
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Significant experience of successfully managing and using large quantities of adverse incident data for evaluation and reporting, providing information on complex and technical matters.

• Experience of working directly with external stakeholders, including system suppliers.
• Significant experience in leading projects to time demonstrating efficient and effective organisation and delivery skills.
• 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.
• Detailed knowledge of the data standards, taxonomies and systems involved in the reporting and management of adverse incidents and signal management to support business processes, including sharing knowledge 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 candidates, find out more here.
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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: Detailed knowledge of the data standards, taxonomies and systems involved in the reporting and management of adverse incidents and signal management to support business processes, including sharing knowledge externally with stakeholders.
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.

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)
• 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

Lead the development and enhancement of Yellow Card systems including API development to ensure continual improvement and that enhanced systems meet the needs of the Patient Safety Monitoring Function including all relevant data fields and standards are met.

• Responsible for delivery of key projects relating to the vigilance system including grant funded projects and use of AI technology to enable coding of incident reports and enabling signal detection systems.
• To lead interactions with suppliers and across the Agency with regards to the optimisation of vigilance system enhancements encouraging collaboration across areas and seeking wider input where necessary.
• To represent the Agency at external vigilance networks and events to ensure implementation of front-end Yellow Card systems reflect stakeholder feedback.
• To lead vigilance project collaborations with external partners and seek out opportunities for improvement in our vigilance activities, ensuring benefits are measured and to demonstrate efficiencies in processes and systems

WHAT’S THE ROLE?

The post holder will manage the development of the MHRA vigilance system including vigilance system transformation work. Accountable for key vigilance development projects including system collaborations with external partners and engagement with strategic stakeholders in the UK healthcare system and internationally for Adverse incident data collection & signal detection activities. The post holder will lead development of the Yellow Card platform and Vigilance Hub to ensure high level service delivery and continuous system and business process improvement for all medicinal product types.
The role reports to the Head of Vigilance development.

KEY RESPONSIBILITIES:

• Lead the development and enhancement of Yellow Card systems including API development to ensure continual improvement and that enhanced systems meet the needs of the Patient Safety Monitoring Function including all relevant data fields and standards are met.

• Responsible for delivery of key projects relating to the vigilance system including grant funded projects and use of AI technology to enable coding of incident reports and enabling signal detection systems.

• To lead interactions with suppliers and across the Agency with regards to the optimisation of vigilance system enhancements encouraging collaboration across areas and seeking wider input where necessary.
• To represent the Agency at external vigilance networks and events to ensure implementation of front-end Yellow Card systems reflect stakeholder feedback.
• To lead vigilance project collaborations with external partners and seek out opportunities for improvement in our vigilance activities, ensuring benefits are measured and to demonstrate efficiencies in processes and systems.

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