SayPro Head of Vigilance Operations

We are currently looking for aHead of Vigilance Operationsto join ourPatient Safety MonitoringFunction within theSafety & Surveillancegroup.

This is afull-timeopportunity, on apermanentbasis. 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.

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.

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.

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

What’s 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 readour 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.

• 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.