We are currently looking for a Benefit Risk Evaluation Assessor – Software to join our Benefit Risk Evaluation I Team within the S afety & 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 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 LOOKING FOR?

Our successful candidate will have:

• Degree or equivalent qualification in a health care, regulatory or health data science/analytics (such as medical engineering, material science, or healthcare qualification); and/or Previous relevant experience gained in healthcare, medical device manufacturing, regulatory environment, or health data science.
• Technical knowledge or practical experience of a range of software medical devices is preferable.
• Experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressure and make appropriate recommendations or decisions to protect patient safety/public health even when the evidence is not clear. Implement appropriate actions to mitigate risk
• Evidence of writing well-structured, concise, authoritative reports to support decision making on drug / device safety and provide technically sound information to stakeholders.
• Sharing knowledge to improve patient safety

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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WHAT’S THE ROLE?

We have available two exciting opportunities within the Benefit-Risk Evaluation group, a critical component of Safety and Surveillance. Reporting to the Biosafety, Nonclinical and Emerging Technologies TAU Head, the assessor will provide technical and regulatory expertise and leadership on software as a medical device to the Benefit Risk Evaluation Group, the Software and AI Group and across the wider MHRA. The post holders are required to use a range of data sources to undertake trending activities and identify safety signals for further investigation. Additionally, post holders will also contribute to the development of the regulatory framework for software as a medical device.

KEY RESPONSIBILITIES:

• Actively participate in meetings and work programmes to assess safety signals involving software as medical devices; effective management of trending activities and safety signal reports ensuring cases are kept up-to-date and quality of work is maintained.
• Provide specialist technical advice and support on software as a medical device to other colleagues and senior officials to meet divisional business needs and targets.
• Undertake technical reviews of software as a medical device as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients.
• Develop and implement regulatory changes on software as a medical device through legislative reform and clarificatory guidance, and provide advice and guidance to stakeholders as this evolves.

The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical, scientific, clinical and regulatory knowledge, and practical experience. The team conducts benefit-risk evaluations for medicines and medical device across a broad spectrum of therapeutic areas to guide actions that protect patient safety. The team is responsible for:

• 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
• Exploiting data and embracing new technologies to develop the evidence to support our actions and understand their impac

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