Clinical Safety Officer - London, United Kingdom - Skin Analytics
Description
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.
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 role:
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.
Requirements:
Essential:
- 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
- Critical appraisal and logical reasoning skills
- Problemsolving 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 selfstarter, 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 eprescribing 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 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. _
Benefits
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 catchups, monthly meetings to talk about you, and your ambitions and make plans
- Lots of fun social activities
The Real Stuff
Skin 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.
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