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Clinical Safety Officer

Reporting to

Senior Clinical Safety Officer

Location

Office based - either Warrington or Nottingham (with some travel to other sites)

Background

An opportunity has arisen to join the clinical safety team. The Clinical Safety Officer (CSO), will have responsibility for establishing and maintaining Clinical Safety Compliance for all products considered ‘in scope’ within the System C and Graphnet Care Alliance (referred to from this point as ‘System C’) 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.

Duties and Responsibilities:

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 System C, becomes and remains fully compliant with the internal standards and policy and external regulations;
  • Managing all safety-related incidents within System C 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 System C 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 System C’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 System C’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.

Skills and Experience:

The post-holder must have knowledge / experience of:

  • Clinical qualifications, Midwifery/Maternity experience preferred, and background within the NHS / private healthcare
  • 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 with at least 5 years’ clinical experience
  • Ability to work with a high degree of autonomy
  • 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

Applications

Please apply in writing, sending a covering letter & CV to hrrecruitment@systemc.com