Head of Respiratory, Critical Care and Imaging

6 months ago

London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

We are currently looking for a **Head of Respiratory, Critical Care and Imaging** to join our **Benefit Risk Respiratory Critical Care and Imagining Evaluation **Team 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 4 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 8 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

**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 new Safety Connect System.

Medicines and devices have traditionally been regulated separately largely driven by different regulatory processes and ways of working. As science and technology drives increasing understanding of disease, it is also opening new opportunities for treatments with both functions. Product profiles are changing, becoming ever more complex and the boundaries between functions are blurring. These changes provide a unique opportunity to bring functional 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 core objective of the Safety & Surveillance Group 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 purpose of this role is to provide strategic leadership and management to a team of benefit-risk evaluation assessors in defined therapeutic areas within the Risk/Benefit function to ensure that safe and effective medicines and medical devices continue to be available to UK patients. The post holder will bring together medicine and medical devices expertise to ensure effective matrix working across the Benefit-Risk Evaluation functions, the wider Safety and Surveillance Group and Agency life-cycle Groups to see that scientific, technical, non-clinical and clinical benefit-risk assessment of potential safety issues takes place promptly and contributes to sound regulatory decisions regarding safety and performance.

**Key responsibilities**:

- Lead and manage the Benefit Risk Evaluation work of the therapeutic team in line with One Agency aspirations to ensure the effective contributions to, and delivery, of the Agency business plan in their defined therapeutic area in this case Respiratory, Critical Care and Imaging.
- Provide leadership to a diverse team of scientific, technical, non-clinical and clinical staff, including developing SMART objectives, ensuring a high standard of benefit risk evaluation and supporting professional development.
- Effective management of the therapeutic team to ensure operational efficiency and continuous quality improvement to maintain adherence to Agency performance measures, Group targets, benefit risk assessment deadlines, ensuring allocation of resources to effectively meet targets and ensure patients and the public are involved in all aspects of benefit-risk decision making to improve patient safety outcomes.
- Ensure the therapeutic team can make autonomous decisions based on the available evidence, accepting that evidence may be incomplete and/or inconclusive, seeking expert advice and/or Expert Advisory Committee support where necessary.

**Who are we looking for?**
- Be open and transparent and puts patients and patient

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