Benefit Risk Evaluation Assessor - Software
Job summary
****TO APPLY FOR THIS ROLE, PLEASE ENSURE YOU CLICK THE LINK TO APPLY BUTTON (UNDER SUPPORTING LINKS). This will redirect you to Civil Service Jobs to submit your application. WE WILL NOT BE REVIEWING APPLICATIONS SUBMITTED VIA THE NHS JOBS WEBSITE****
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.
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 Agency's data and evidence generating capabilities, complementing our signal generating abilities.
Main duties of the job
Job description
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
About us
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.
Job description
Job 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.
Effective management of risk / benefit management reports (risk analysis, risk control and risk
evaluation) to ensure robust and timely regulatory decisions for software as a medical device.
Ensure patient experience informs benefit risk decisions by identifying and providing opportunities for patient involvement in benefit risk evaluations.
Process, manage and draft correspondence within own area of business including safety messages and other safety advice documents.
Represent Agency at advisory and external meetings, high profile issues and topical issues to
provide authoritative up to date advice and regulatory position.
Be the lead benefit risk evaluation assessor for safety on Expert Advisory groups and/or short life working groups as appropriate to support effective benefit risk evaluations of potential safety issues.
Lead/contribute safety expertise to national and international committees and fora to set and improve standards for medical products.
Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals.
Be proactive in contributing to developments in issues relating to software as a medical device, its use and regulation.
Person Specification
Knowledge
- Technical knowledge or practical experience of a range of software medical devices is preferable
Qualifications
- 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
Behaviours
- Managing a Quality Service - Proven ability to adapt to changing or conflicting priorities and new ways of working, taking responsibility for achieving a successful outcome within necessary timelines, whilst maintaining effective performance under challenging circumstances
- Communicating and Influencing: Ability to communicate with others internal and external to the agency in a clear, honest and enthusiastic way in order to explain complex issues and to build trust.
- Seeing the Big Picture - Ensure plans and activities in your area of work reflect wider strategic priorities and communicate effectively with senior leaders - Support, develop or deliver improvements and improved ways of working across benefit risk evaluation, safety and surveillance and the wider agency.
Experience
- Proven understanding of risk management principles to reduce harm (direct or indirect), preferably related to software as a medical device
- 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
- Evidence of delivering clear and focussed presentations that are tailored to the needs of the audience
- Sharing knowledge to improve patient safety and showing willingness to learn from others
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details
Employer name
Medicines and Healthcare Products Regulatory Agency
Address
Medicine & Healthcare Regulatory Agency
10 South Colonnade
London
E14 4PU
Employer's website
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
- Company
- Medicines and Healthcare Products Regulatory Agency
- Location
- London, United Kingdom E14 4PU
- Employment Type
- Permanent
- Salary
- £58983.00 a year
- Posted
- Company
- Medicines and Healthcare Products Regulatory Agency
- Location
- London, United Kingdom E14 4PU
- Employment Type
- Permanent
- Salary
- £58983.00 a year
- Posted