1000+ Best day care Jobs in London (August 2025) - page 17

Medicines and Healthcare products Regulatory Agency

Benefit Risk Evaluation Assessor - Software

19 days ago

London

Description We are currently looking for a Benefit Risk Evaluation Assessor Softwareto join our Benefit Risk Evaluation I Team within the Safety & Surveillancegroup. This is a full-timeopportunity 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 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 (S&S) Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agencys data and evidence generating capabilities complementing our signal generating abilities. Against this background and the drive to improve treatment availability for patients safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying assessing and managing the risks associated with medical every aspect of this work we harness the best science technology information and professional practice to protect patients in new and impactful ways. 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 impact Whats 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. Who are we looking for Oursuccessful candidatewill 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 ___ If you would like to find out more about this fantastic opportunity please read * * * * * * * ___Description We are currently looking for a Benefit Risk Evaluation Assessor Softwareto join our Benefit Risk Evaluation I Team within the Safety & Surveillancegroup. This is a full-timeopportunity 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 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 (S&S) Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agencys data and evidence generating capabilities complementing our signal generating abilities. Against this background and the drive to improve treatment availability for patients safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying assessing and managing the risks associated with medical every aspect of this work we harness the best science technology information and professional practice to protect patients in new and impactful ways. 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 impact Whats 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. Who are we looking for Oursuccessful candidatewill 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 * * * * * * * ___Description We are currently looking for a Benefit Risk Evaluation Assessor Softwareto join our Benefit Risk Evaluation I Team within the Safety & Surveillancegroup. This is a full-timeopportunity 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 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 (S&S) Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agencys data and evidence generating capabilities complementing our signal generating abilities. Against this background and the drive to improve treatment availability for patients safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying assessing and managing the risks associated with medical every aspect of this work we harness the best science technology information and professional practice to protect patients in new and impactful ways. 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 impact Whats 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. Who are we looking for Oursuccessful candidatewill 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 * * * * * * *

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