Big Picture Medical
Big Picture Medical United Kingdom United Kingdom
3 months ago
A new opening for a Clinical Safety Officer to join a data-driven, technology-focused, and agile HealthTech company. The successful candidate will offer a deep knowledge of Clinical Safety Compliance and Risk Management and will be seen as an authority and primary point of contact for all matters relating to clinical safety. They will work with design, product, and engineering teams to develop and implement smooth proactive processes for clinical safety regulatory documentation. They will be responsible for the DCB0129 assessment, documentation, and sign-off.
Based in the United Kingdom. You will report to the Clinical Director
It should be noted that this is an international company with a headquarters in Sydney and another base in London. The role will occasionally involve evening or early morning calls (a couple a month)
• Establishing and maintaining the company-wide clinical safety methodology and processes.
• Full end-to-end safety and risk assessment... across the product and software ensuring that every product and associated service becomes and remains fully compliant with internal standards and policy and external clinical safety requirements.
• Maintaining Clinical Risk Management documentation required by DCB0129.
• Managing all safety-related incidents to ensure minimum risk and exposure including participation in the on-call rota;
• Raising staff awareness of clinical safety best practice compliance within the business;
• Ensuring all affected standard operating procedures and business processes are updated to incorporate relevant patient safety / clinical risk procedures and activities;
• Engagement with other clinical staff to ensure the safe design and implementation of the product.
What you’ll do
• Leading the clinical risk management function within the organisation - scoping definition, clinical hazards identification, clinical risk estimation, clinical risk evaluation, and clinical risk control.
• Leading investigation, prioritisation and resolution of safety issues under the direction of the Clinical Director.
• Executing root cause analysis of safety incidents that have been raised in line with best guidance practice
• Helping/advising the organisation when performing corrective actions arising from Safety Incident Reports
• Managing safety incidents to minimise actual risk and commercial exposure.
• Clinical qualifications and background within the NHS / private healthcare
• Needs to be currently registered with a clinical professional body
• Attended an accredited CSO course
• Project Management skills, principles, and practices
• Knowledge of DCB0129 requirements
• NHS informatics experience
If this sounds like your next challenge, get in touch – [email protected]
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