Head of Vigilance Development

We are currently looking for a Head of Vigilance Development 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.

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. 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 post holder will lead development of the MHRA vigilance system, including vigilance system transformation work, to ensure continuous improvement of joined-up systems and processes for all medicinal product types. Accountable for key projects within the Patient Safety Monitoring Function and engagement with strategic stakeholders in the UK healthcare system for adverse incident data collection and signal management processes. This role leads delivery of continuous vigilance systems improvements to support collection and assessment of reaction and adverse incidents. Systems under the role’s responsibility include the public facing Yellow Card scheme as well as industry reporting portals, such as reporting for pharmaceutical companies, device manufacturers and blood incidents. The main objectives are to work across the Agency and Health network to ensure MHRA has the information necessary to assess potential harms from medicinal products and take appropriate regulatory action as swiftly as possible.

Key responsibilities:

• Lead the development and enhancement of Safety & Surveillance IT systems and processes for the Patient Safety Monitoring Function to ensure continual improvement and best use of available resources for adverse incident data management and signal management activities ensuring the quality management system for vigilance activities is updated in line with new and incoming procedures, technologies and legislation.
• Collaborate and build relationships across the Agency and the UK Health Family to ensure vigilance systems are integrated with appropriate datasets, data standards and terminologies.
• Accountable for setting strategic direction and leading delivery of key projects arising from Yellow Card strategy recommendations and stakeholder engagement, as directed by the Senior Leadership Group.
• Represent the Agency at stakeholder working groups to develop best practice recommendations and foster new alliances for adverse incident data collection and other vigilance activities.

Who are we looking for? Our successful candidate will have the following:

Experience:

• Extensive experience of successfully managing and using large quantities of adverse incident data for evaluation and reporting, providing information on complex and technical matters.

Behaviours:

• Leadership – Welcome and respond to views and challenges from others, despite any conflicting pressures to ignore or give in to them. Stand by, promote or defend own and team’s actions and decisions where needed. Seek out shared interests beyond own area of responsibility, understanding the extent of the impact actions have on the organisation. Inspire and motivate teams to be fully engaged in their work and dedicated to their role to create a culture of high performance and continuous improvement.
• Seeing the Big Picture – Ensure plans and activities in your area of work reflect wider Agency and government strategic priorities and communicate effectively with senior leaders to influence future strategies. Bring together views, perspectives and diverse needs of stakeholders to gain a broader understanding of the issues surrounding policies and activities.

Technical:

• Detailed knowledge of the data standards, taxonomies and systems involved in the reporting and management of adverse incidents for the maintenance and performance of business processes within Patient Safety Monitoring.
• Strong knowledge and understanding of medicines and medical device regulation for post marketing surveillance.

Person Specification:

Method of assessment: A=Application, I=Interview

Behaviour Criteria:

• Seeing the Big Picture (A, I)
• Leadership (A, I)
• Communicating and Influencing (A, I)

Experience Criteria:

• Extensive experience of successfully managing and using large quantities of adverse incident data for evaluation and reporting, providing information on complex and technical matters. (A, I)
• Project management experience, demonstration of successful delivery of projects to agreed timescales and budgets with deliverables of high quality (A, I)
• Knowledge of both medicines and medical devices legislative landscape and associated data standards and terminologies (A, I)
• Extensive experience of working with international projects and with other international regulators to ensure collaborative working and delivery. (A, I)
• Experience working with innovative technologies to deliver benefits to vigilance systems (A, I)

Technical Criteria:

• 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)
• Detailed knowledge of the data standards, taxonomies and systems involved in the reporting and management of adverse incidents for the maintenance and performance of business processes within Patient Safety Monitoring. (A)
• Effective presentation and communication skills, including excellent writing skills for preparing and independently writing briefing / formal reports. (A)
• Strong knowledge and understanding of medicines and medical device regulation. (A)

Closing date: 19 February 2026

Shortlisting date: From 20 February 2026