Lead Quality and Patient Safety Strategist
Company
Location
Reading, England, United Kingdom
Posted At
12/3/2024
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Description
Job Description
The qualified candidate will collaboratively work with product teams to ensure understanding and provide oversight to the development of the required DCB0129 artifacts. As an NHS certified Clinical Safety Officer (CSO), you will sign the required artifacts when the artifacts have appropriately met the standards. Additionally, you will participate in the Global Clinical Risk Management framework and governance processes to ensure maintenance occurs with the required artifacts.
As part of the oversight of product quality and safety, you will also be responsible for key aspects of the Internal Complaint Handling process. This requires communication and collaboration with all levels of management; facilitating cross-functional investigations; managing the mitigations and resolution of formal complaints. You will also assist product teams with formal communication of an issue to the customer base, consult/assist with root cause analysis, preventative actions, and present updates to executives. All efforts of the Complaint Handling process also serve an important aspect of continual evaluation and maintenance of the DCB0129 artifacts.
We are looking for someone with a strong capability to learn, excellent project management, and strong verbal and written communication skills. You will be a part of an international team where collaboration and teamwork are the foundation for success.
Responsibilities
Career Level - IC4
Responsibilities
Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Support the creation of a comprehensive risk management and/or quality management, and regulatory oversight program, including specifications for product and service design aligned with Oracle Software Security Assurance and Security Architecture, and/or Quality Management systems. Review specifications. Develop training for GBU development, cloud services, services and operations teams on industry regulatory specifications applicable to their products and services. Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies. Identify industry requirements applicable to Oracle GBUs, and work with members of GBU development, cloud services, services and operations teams to incorporate applicable industry regulatory standards, Oracle security and/or quality policies and customer-contractual obligations into GBU processes and standards. Coordinate industry and regulatory certifications, including managing certification vendors (e.g., PCI, HIPAA,HITECH, ISO, SOC2). Build security documentation and collateral for customers and internal users allowing security to be a differentiator in this GBUs. Build management level metrics and reporting for activities that are owned by the Risk Manager. Execute a vendor security and/or quality management program.
About Us
As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s problems. True innovation starts with diverse perspectives and various abilities and backgrounds.
When everyone’s voice is heard, we’re inspired to go beyond what’s been done before. It’s why we’re committed to expanding our inclusive workforce that promotes diverse insights and perspectives.
We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer a highly competitive suite of employee benefits designed on the principles of parity and consistency. We put our people first with flexible medical, life insurance and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by calling +1 888 404 2494, option one.
Disclaimer:
Oracle is an Equal Employment Opportunity Employer*. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
The qualified candidate will collaboratively work with product teams to ensure understanding and provide oversight to the development of the required DCB0129 artifacts. As an NHS certified Clinical Safety Officer (CSO), you will sign the required artifacts when the artifacts have appropriately met the standards. Additionally, you will participate in the Global Clinical Risk Management framework and governance processes to ensure maintenance occurs with the required artifacts.
As part of the oversight of product quality and safety, you will also be responsible for key aspects of the Internal Complaint Handling process. This requires communication and collaboration with all levels of management; facilitating cross-functional investigations; managing the mitigations and resolution of formal complaints. You will also assist product teams with formal communication of an issue to the customer base, consult/assist with root cause analysis, preventative actions, and present updates to executives. All efforts of the Complaint Handling process also serve an important aspect of continual evaluation and maintenance of the DCB0129 artifacts.
We are looking for someone with a strong capability to learn, excellent project management, and strong verbal and written communication skills. You will be a part of an international team where collaboration and teamwork are the foundation for success.
Responsibilities
- Collaborate and facilitate Clinical Risk Management functions to ensure compliance with the DCB0129 standard.
- Work with the Regulatory Strategy team who outlines the specifics required to adhere to the DCB0129 standard.
- Support the execution of the Complaint Handling process, including facilitating, monitoring and trending.
- Provide clear expectations and responsibilities of the complaint handling process to product engineering teams and business stakeholders.
- Ability to evaluate dashboards and confidently discuss results and trending with executives.
- Identifying, researching and driving opportunities for process and program improvements
- Ability to communicate in remote working environments over video, phone, email, and other tools
- Collaborate with subject matter experts to refine operating processes to increase the value and scale of our Complaint Handling program and decrease the operational impact to Oracle.
- Confidently communicate escalations and status of open complaints to management.
- Bachelor's r in Nursing, Clinical Studies, Healthcare or related field, or 4 years relevant work experience
- Minimum 2 years of licensed healthcare practice experience
- Minimum 4 years of clinical healthcare information technology (HCIT) and leadership work experience
- Experience of working within the NHS or knowledge of Oracle (Cerner) products
- Clinical license registration in nursing, pharmacy, medicine, allied health, or another clinical field
- Certified Clinical Safety Officer in the UK or possesses the necessary qualifications to become a Clinical Safety Officer in the UK.
- Leadership experience
- Excellent written and verbal communication skills
- Strong analytic skills
- Strong attention to detail
- Ability to manage multiple projects and deadlines
- Ability to work in a team and collaborative environment
- Ability to work and adapt in an ever-changing, dynamic environment
- At least 3 year of Health Information Technology or Health Regulatory Compliance work experience.
- JIRA and Confluence experience
Career Level - IC4
Responsibilities
Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Support the creation of a comprehensive risk management and/or quality management, and regulatory oversight program, including specifications for product and service design aligned with Oracle Software Security Assurance and Security Architecture, and/or Quality Management systems. Review specifications. Develop training for GBU development, cloud services, services and operations teams on industry regulatory specifications applicable to their products and services. Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies. Identify industry requirements applicable to Oracle GBUs, and work with members of GBU development, cloud services, services and operations teams to incorporate applicable industry regulatory standards, Oracle security and/or quality policies and customer-contractual obligations into GBU processes and standards. Coordinate industry and regulatory certifications, including managing certification vendors (e.g., PCI, HIPAA,HITECH, ISO, SOC2). Build security documentation and collateral for customers and internal users allowing security to be a differentiator in this GBUs. Build management level metrics and reporting for activities that are owned by the Risk Manager. Execute a vendor security and/or quality management program.
About Us
As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s problems. True innovation starts with diverse perspectives and various abilities and backgrounds.
When everyone’s voice is heard, we’re inspired to go beyond what’s been done before. It’s why we’re committed to expanding our inclusive workforce that promotes diverse insights and perspectives.
We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer a highly competitive suite of employee benefits designed on the principles of parity and consistency. We put our people first with flexible medical, life insurance and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by calling +1 888 404 2494, option one.
Disclaimer:
Oracle is an Equal Employment Opportunity Employer*. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
- Which includes being a United States Affirmative Action Employer
Advertise with us.
Please contact: hello@huntukvisasponsors.com
Please contact: hello@huntukvisasponsors.com
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