Job purpose

To provide and implement clinical safety management strategies and best practice methodologies and to ensure compliance of clinical safety standards and MHRA medical device directives (MDD).

The Clinical Safety Officer (CSO) is required to have spent a minimum of 5 years working within a Health or Social Care environment and have a sound knowledge of any or all of the following:

  • Hospital Pharmacy Stock Control
  • Electronic Prescribing and Management Administration (EPMA) systems.
  • Chemotherapy Management Systems.
  • Clinical IT systems.
  • It would be an advantage to have completed and passed the NHS Digital Clinical Safety Officer Accreditation programme.

Candidates with appropriate, qualifications in and knowledge of Clinical Risk Management Processes are preferred.

Reports to:

JAC Chief Executive Officer

Location:

Although you will be expected to work at our Basildon office flexible arrangements for home working are available

Key responsibilities and accountabilities:

The principle responsibilities and accountabilities of the CSO include, but are not limited to, the following:

Context:

  • Review clinical safety guidance, standards, legislation and research.
  • Monitor compliance with DCB 0129 Implementation Guidance.
  • Produce a compliance risk register to identify the level of compliance.
  • Actively engage in improvement tasks to establish and maintain an acceptable level of compliance.

Routine Activity:

  • Plan work and keep weekly diary up to date and shared with appropriate colleagues.
  • Perform a clinical assessment and assign a clinical risk level to all recorded issues.
  • Provide advice and guidance on any aspect of clinical safety, as required, to all departments.

On Demand Activity:

  • Participate in Build Documentation – Release Management (BDRM) strategy.
  • Record the start of all new clinical safety documents in the BDRM system.
  • Report on progress of document production seeking review and approval, in the BDRM strategy.
  • Perform document reviews for other departmental authors.
  • Prepare or Review and approve safety documentation prepared by other Product Specialists including:
    • Clinical Safety Case Report
    • Hazard Log

Strategic Activity:

  • Provide Clinical Safety Training in accordance with Information Security and Quality Management (ISQMS) requirements.
  • Provide specialist knowledge to Sales and Marketing Team as requested.
  • Provide specialist knowledge to Account Managers, as requested and participated in Regional and National JAC User Groups.
  • Perform an annual review of the JAC Clinical Risk Management Strategy CRMS), make amendments, as necessary, before seeking approval for the new version.
  • Adhere to the principles outlined in the Company’s CRMS and accept delegated responsibility, from the Chief Executive Office, to deliver all aspects of the Clinical Safety Process as detailed in the strategy.
  • Appreciate that decisions about risks to patients posed by a Health IT Product in a clinical environment need to involve appropriate, experienced and knowledgeable colleagues.
  • Recognise that a respectful working relationship with senior colleagues will ensure the provision of suitably qualified and experienced personnel to operate the Clinical Risk Management Process effectively.

STANDARDS OF PERFORMANCE

  • Compliance to DCB 0129 and ISQMS Standards as applicable to the Company
  • Excellent English writing and IT literacy skills

ESSENTIAL FUNCTIONS

The Clinical Safety Officer will retain overall responsibility for the following activities:

Clinical Safety

  • Review and execution of clinical safety risk management process, to maintain continuous improvement
  • Organise and conduct risk assessment sessions for JAC products
  • Complete clinical safety documentation for certification of products e.g. safety reports, safety related procurement responses, functional requirements
  • Engage with, establish and maintain good working relationships with users, both clinical and non-clinical
  • Ensure proper execution of the clinical safety incident reporting system• Engage with the product safety group in the analysis and resolution of reported clinical safety incidents
  • Liaise with respective product specialists, design and development team in resolving safety critical queries and incidents
  • Monitor and conduct verification of safety features and safety functions
  • Review clinical safety guidance, standards and legislation; completing a detailed analysis and assessment of the impact on products as is currently in progress in line with the medical device directive
  • Participate in client activities, including input into National and Regional User Groups

Design

  • Assist the design team in establishing a clinical understanding of the design requirements for a project from the clinical user prospective
  • Create case scenarios for the design stage
  • Review design requirements with Product Manager from a safety perspective
  • Arrange and conduct clinical safety assessment of the design proposal to design out risk
  • Contribute to the compilation of the specification and design requirements documentation ensuring clinical safety perspective is captured
  • Design test plans, specify and create test material and execute clinical solution testing
  • Ensure completion of compliance, certification and clinical governance

Information Standards

  • Review, and record relevant information standards as they are released
  • Complete analysis of relevant standards including a preliminary clinical safety risk review
  • Where applicable compile documentation for the Product Manager for inclusions on to the JAC development roadmap
  • Create a document to cross reference all relevant standards for compliance monitoring

MINIMUM TRAINING REQUIREMENTS

NHS Digital Clinical Safety Officer Accreditation programme (This will be provided by the company if the successful candidate is not currently Accredited)

Other Requirements:

It is the overall goal of the company to develop its current and future markets and the Clinical Safety Officer will be expected to recognise and support the business objectives of the company. These include:

  • Being able to travel both within current and future markets as may be deemed necessary from time to time.
  • Understanding, supporting and communicating both internally and externally the company’s vision and goals.
  • Understanding the financial targets of the company and recommending activities in support of these targets.

Remuneration:

Salary:

Negotiable based upon experience

Benefits:

  • Eligibility to join the company pension scheme.
  • Eligibility to join the company bonus scheme.
  • Expenses as per the company’s policy.
  • 25 days leave a year.
  • Relocation assistance (if appropriate).

To apply

Please submit your CV and letter of application to denise.allars@jac.co.uk

Closing date for applications: Friday 24th May 2019