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Vigilance Collaborations Specialist

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Job Location drjobs

London - UK

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Description

We are currently looking for a Vigilance Collaborations Specialistto join our Patient Safety Monitoring Function within the Safety and Surveillance group.

This is a full-timeopportunity on a 1 year fixed term contract/internal move or temporary promotionbasis. 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.

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.

Whats 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.

Who are we looking for

Oursuccessful candidatewill have:

  • 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 readour 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

The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

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 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:25 August 2025

Shortlisting date: From 26 August 2025

Interview date:w/c 08 or 15 September 2025

Candidates will be given at least one week notice if offered an interview and outcomes of any interviews will be communicated within one week.

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:

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



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 vigilance systems 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.


Qualifications

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.




Required Experience:

Unclear Seniority

Employment Type

Contract

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