Clinical Safety Officer
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| Job Type | Permanent |
| Area | Warrington, United Kingdom |
| Sector | ITHealthHealth - Health or Social Care |
| Start Date | |
| Job Ref | LH9903R |
- Description
Salary: £48,000 to £53,000 DOE + Car Allowance of £5,655 per annum
YOU MUST BE A CLINICIAN WITH A MINIMUM OF 5 YEARS CLINICAL EXPERIENCE AND CURRENTLY REGISTERED ON YOUR RELEVANT PROFESSIONAL REGISTER
The Clinical Safety Officer (CSO), has responsibility for maintaining Clinical Safety Compliance for all products considered ‘in scope’ within the alliance of companies.
This role is a full time position with participation in the on-call rota.
The post holder must have knowledge / experience of:
· Strong current knowledge of a variety of clinical workflows within the NHS/private healthcare setting
· Needs to be currently registered with a professional clinical body
· Knowledge of the Medical Device Regulation and DCB0129 and 0160 standards and requirements
· Has attended (or will be expected to attend) an accredited CSO course
· NHS informatics experience
· Project Management skills, principles and practices
· System analysis, design, development, testing, release, support & maintenance best practice and lifecycles
· NHS and wider Healthcare market / suppliers / competitors
The post-holder must have the following skills:
· Current Clinical qualification, with at least 5 years’ clinical experience
· Working knowledge of MS Office Products
· Management and organisational skills
· Excellent communication and interpersonal skills
· Positive attitude
· Power and ability to make decisions
· Negotiating skills
· Strong analytical and troubleshooting skills
· Ability to exhibit patience and understanding
As Clinical Safety Officer you have responsibility for:
· Maintain the company-wide clinical safety methodology and processes
· Ensure that every product in scope remains fully compliant with the internal standards and policy and external regulations
· Manage safety-related incidents within the company to ensure minimum risk and exposure
· Raise staff awareness of clinical safety best practice compliance within the business
· Ensure all affected standard operating procedures and business processes are updated to incorporate relevant patient safety / clinical risk procedures and activities
· Engage with other clinicians to ensure the safe design and implementation of the company product suite
· Participate in clinical risk assessment activities for products as directed; including assessing and triaging safety incidents
· Perform safety activities and produce safety documentation as described in the company’s Clinical Safety Plan ensuring end to end safety has been carried out on all projects
· Lead investigation, prioritisation and resolution of safety issues under the direction of Senior Clinical Safety Officer (SCSO)
· Take part in root cause analysis of safety incidents in line with best guidance practice
· Help/advise the organisation when performing corrective actions arising from Safety Incident Reports
· Provide clinical safety guidance and steer in accordance with best practice
· Maintain and update Clinical Safety Files for assigned products
· Collaborate with external CSO’s e.g. NHSD , Health Organisations’ and Regulators
· Assist with external auditors and follow through all recommendations raised
· Take part in on call and out of hours responsibilities providing clinical safety review and advice in the event of a clinical safety event
· Maintain clinical registration and competence sufficient to discharge the clinical safety role
· Undertake or assist any further reports or safety work under direction of SCSO e.g. Monthly and Annual Safety Reports, product Safety Cases, Patient safety assessments, Hazard Logs etc for assigned products across the alliance
