Clinical Safety Officer

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 establishing and maintaining Clinical Safety Compliance for all products considered ‘in scope’ within the alliance of companies in accordance with the Clinical Safety Management System (CSMS). Additionally, the CSO will be seen as a leading authority and a primary point of contact for all matters relating to clinical safety.

This role is a full time position with participation in the on-call rota.

The post holder must have knowledge / experience of:

·         Clinical qualifications and background within the NHS/private healthcare preferably within a Maternity setting

·         Needs to be currently registered with clinical professional body

·         Knowledge of standards and DCB0129 and 0160 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:

·         Clinical qualification, preferably Maternity, with at least 5 years’ clinical experience

·         Working knowledge of MS Office Products

·         Management skills

·         Excellent communication and interpersonal skills

·         Positive attitude

·         Strong organisational skills

·         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:

·         Establishing and maintaining the company-wide clinical safety methodology and processes applied throughout our UK business

·         Ensuring that every product and associated service considered ‘in scope’ within the company, becomes and remains fully compliant with the internal standards and policy and external regulations

·         Managing all safety-related incidents within the company 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 clinicians to ensure the safe design and implementation of the company product suite

 Key duties:

·         Owning clinical risk assessment activity for all products or within the organisation as directed; this includes assessing and triaging safety incidents raised by the company’s Clinical Safety Incident Management Systems

·         Acting as the figurehead for safety work on assigned projects internal and this includes completing safety work as documented in the company’s Clinical Safety Plan

·         Leading investigation, prioritisation and resolution of safety issues under direction of Senior Clinical Safety Officer (SCSO)

·         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

·         Providing clinical safety guidance and steer

·         Executing (or commissioning) human factors assessment where appropriate

·         Providing guidance on clinical safety best practice

·         Maintaining and updating 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

·         On call and out of hours responsibilities providing clinical safety review and advice in the event of a clinical safety event both in office hours and out of hours on a rota basis

·         Ensuring end to end safety has been carried out on all projects

·         Maintaining 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

·         Produce and maintain Monthly, Emergency Patch Reports, Safety Cases, Patient safety assessments, Hazard Logs etc. for each assigned product across the alliance