Clinical Safety Officer Job in – O, POST-LON
Requisition ID :51173752Posting
Category : Strategy and Industry Group
Job Family : Emerging Practices
Location: 0, POST-LON GB
Schedule: Full Time
Global Clinical Safety is a Team of Suitably Qualified and Experienced Personnel. The great majority of those have clinical backgrounds across a wide range of professions.
The Clinical Safety Officer provides the day to day expertise into the broader DXC development. They have a level of experience that allows them to:
communicate with authority on matters regarding the business needs of the customer;
provide understanding regarding the business processes the customer employs; and,
contextualize the impact of the wider health care domain on the solution for the development teams.
The Clinical Safety Officer works end to end across the product lifecycle within the parameters of the software development lifecycle. They are responsible for the maintenance and review of the Hazard Register and the creation of the key clinical safety deliverables. They will also provide assistance in advising how to mitigate the clinical risks they identify.
Although based in the UK, the role will extend to supporting colleagues in other geographies. This will include helping with the creation of product safety cases, working with product teams, and reporting to product owners and executives.
The role will also include being part of the clinical safety consultancy team. Consultancy includes supporting customers in identifying key process issues that may lead to harm; suggesting mitigations and developing plans to enable cultural change at customers to ensure the benefits identified are realized.
The safety officer will be responsible for:
Embedding of end to end safety and regulatory requirements, gateways and processes into the Software Development Lifecycle as standard.
Ensuring adherence to the required global regulations and legislation for patient safety and product manufacturing, e.g. EU Medical Devices Directive 93/42/EEC.
Assisting with registration and certification of DXC medical device / software products to facilitate sales within the global market.
Ensuring provision of a formalised, top down and cost-effective approach to safety across DXC globally – based on industry best practice, legislation and standards.
Identification of safety risks and issues at earlier stages in product development, resulting in significantly reduced potential for future safety incidents, fewer project delays and, therefore, reduced costs.
Improving overall product quality and end user experience.
Reduction in the likelihood of successful litigation, in the undesirable event of patient safety incidents caused by DXC offerings, due to rigour applied to development with documentary evidence.
Attending internal solution meetings to ensure clinical focus is maintained.
Applying their clinical knowledge to support the development of business process designs to ensure the solution meets the needs of the customer;
Reviewing testing scenarios to ensure that the solution is rigorously tested from a clinical perspective (safety and effectiveness)
Review the outcome of testing to ensure that where necessary functional issues are dealt with in the most efficient manner;
Escalate, where necessary, program or project risks and issues through the appropriate channels;
Participate in the incident management clinical on-call rota
Provide clinical input to problem resolution in live systems.
Product knowledge or experience of using healthcare IT systems
Registerable qualification with a UK professional body or relevant up to date practice within healthcare.
Degree level (or experience equivalent) in a managerial or healthcare related subject.
Strong communication; skills able to deliver a message to people at all levels of the business who will have very different levels of domain knowledge
Demonstrate the knowledge required to meet the DXC expectations of a Suitably Qualified and Experienced Safety practitioner. Suitable candidates who do not have this will be required to attend safety course and maintain this through annual updates.
Provide clinical consultancy and final approval of the product release clinical safety plans. A clinical safety plan describes the necessary clinical safety activities required to meet internal and external safety requirements for a specific product and release. Although standard practice is in place the plan should established for each release to ensure the clinical safety management elements add the most value possible to the production process and timescales.
Excellent interpersonal skills;
Excellent team worker;
Good personal computer skills
Independent self-starter able to work from home with minimal face to face contact
Excellent organization and time management skills
Good analytical and problem-solving skills
Ability to handle varying activities on multiple products and tasks and switch between them quickly to meet prioritized tasks whilst not losing sight of all other task priorities
Ability to deal with and manage change
Ability to complete assigned responsibilities in a given timeframe
Detailed understanding of clinical end to end processes
Broad understanding of the healthcare delivery, especially in the UK health services and the ability to explain the function and structure of the service delivery to non-clinical people;
Provide guidance and support for non-clinical people to be able to understand the clinical hazards and impact assessments.
Note: This job description describes the general nature of the duties and requirements of the job.It is not intended to be an exhaustive list or to limit the scope of any potential assignments or client engagement.