Clinical Safety Officer

About Skin Analytics Skin Analytics is an award-winning digital health company that has launched the world’s first AI-supported Skin Cancer pathway for a faster skin cancer diagnosis. Our AI as a Medical Device (AIaMD) is deployed in 13 NHS organisations, and growing. We are leading the way in leveraging AI technology to address the demand and capacity crisis facing Dermatology safely.We are a team of passionate people who want to build a future where no one dies from skin cancer.As Skin Analytics enters an exciting phase of growth, we are on the search for driven and forward-thinking individuals to join the Clinical Team. About the rolePlease note: This role will be based from our London Office 1-3 days p. week.In this role, you will report to and work closely with the Senior Clinical Safety and Operations Lead, in order to undertake clinical risk management activities, assessing clinical risk (e.g. running hazard identification workshops, risk assessments of new features, risk assessing incidents), and maintaining clinical risk management documentation for our teledermatology platform (Ov2) which is a non-medical device, and other related new digital health platform products as they are scoped and developed. You may also support risk management activities for our Software as a Medical Device (SaMD) products.You will work closely with our partnerships and business development teams to ensure that safety documentation and protocol are complete before the launch of our product and pathways for new customers. You will also work closely with our customer operations and partnerships teams in responding to and escalating customer complaints and queries as they relate to clinical safety, as part of our post-deployment monitoring activities.Other clinical safety responsibilities will include management of clinical governance processes, including the review of consultant dermatologist performance, clinical audits, overseeing e-prescribing practices, and helping us make sure we are always CQC audit ready.The primary focus of this role is for Clinical Safety but aspects of the role will also involve related activities such as being responsible for our accompanying guidance documentation from a clinical / safety perspective. These may include our respective user manuals and training material.Essential Must be able to come to our office in London 1-3 days p. week Suitable clinical qualification(s) and experience
Hold a current registration with an appropriate professional body relevant to their training and experience Have completed appropriate training e.g. NHS Digital’s Clinical Safety Training Knowledgeable in risk management and its application to clinical domains as applied to Health IT Systems, particularly NHS Digital’s Clinical Safety Standard DCB 0129 and/or DCB 0160. Critical appraisal and logical reasoning skills Problem-solving skills
Great written communication skills to work on client materials Great verbal communication skills to communicate both internally and externally regarding customer safety queries Attention to detail Collaborative personality A self-starter, team player and able to work flexibly in a dynamic and rapidly evolving environment Desirable Experience in Clinical Risk Management in the manufacturing of Health IT Solutions (i.e. DCB 0129) for a supplier.
Experience in conducting clinical risk management activities in an appropriate clinical setting.
Experience in Clinical Risk Management in implementing e-prescribing telehealth solutions Knowledge of ISO 14971: Application of Risk Management in Medical Devices Experience and knowledge of clinical risk assessment of Artificial Intelligence digital health solutions Experience in working in an agile development environment Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our employees agree to complete their assigned training and diligently follow all company quality management and information security processes.​​What's in it for you? Competitive salary Share options package - all our employees have shares in the business Private healthcare incl. Partner & children 25 days annual leave (trialling increase to 26 days + Company shutdown in August) Enhanced parental leave - includes adoption & foster Training budget Besides weekly catch-ups, monthly meetings to talk about you, and your ambitions and make plans Lots of fun social activities The Real StuffSkin Analytics embraces and is committed to diversity and equal opportunities. We are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
#J-18808-Ljbffr