Benefit Risk Evaluation Assessor - Software

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

Essential

• Technical knowledge or practical experience of a range of software medical devices is preferable

Qualifications

Essential

• 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

Essential

• 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

Essential

• 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 (Opens in a new tab)