临床安全官
临床安全官是注册临床人员，确保组织构建、购买和部署的医疗信息系统对患者安全。他们运行临床风险管理流程，领导危害识别，负责危害日志，并依据 ISO 14971 和 IEC 80001-1 等临床风险管理标准编写和签核临床安全案例报告。
本文由人工智能助手从英文翻译而来，尚未经过母语人士审校。引自英国政府数字与数据专业能力框架（UK GDaD PCF）和 ESCO 的内容保留英文原文。
- UK GDaD PCF 角色
- 无：本参考资料定义该角色
- ESCO 职业
- clinical informatics manager (ISCO-08 1342); regulatory affairs manager (ISCO-08 2619)
级别
| 职级 | 角色级别 | UK GDaD PCF 级别 | 英国公务员职等 | 岗位评估分数 |
|---|---|---|---|---|
| 7 | 临床安全官 | — | — | 522 |
| 8a | 高级临床安全官 | — | — | 577 |
| 8b | 临床安全主管 | — | — | 619 |
在数字医疗卫生组织中
- 该角色必须由注册临床人员担任，使安全判断建立在最新的临床知识和职业问责之上。
- 医疗信息系统可能通过错误、缺失、延迟或误导性的信息伤害患者，因此该角色评估常常隐藏在数据和工作流程中的风险。
- 临床安全工作贯穿系统的整个生命周期，从设计和采购到部署、变更和退役。
- 一些产品还作为医疗器械受到监管，因此在安全案例与器械文件重叠时，该角色与监管和质量同事合作。
- 涉及医疗信息系统的安全事件可能造成严重伤害，因此该角色调查事件并确保吸取教训。
ESCO 职业与技能
ESCO 列出了雇主对每种职业通常需要（必备）或可能需要（可选）的技能和知识。可将其用作发展谈话的检查清单。
clinical informatics manager
Clinical informatics managers oversee the daily operations of information systems used in a medical institutions. They also carry out research, using their understanding of clinical practices to find ways to improve healthcare services.
必备技能和知识（28）
技能与能力
- adhere to organisational guidelines
- analyse large-scale data in healthcare
- apply good clinical practices
- apply organisational techniques
- collect healthcare user's general data
- communicate in healthcare
- comply with quality standards related to healthcare practice
- conduct clinical software research
- contribute to continuity of health care
- contribute to public health campaigns
- follow clinical guidelines
- oversee clinical information system activities
- perform clinical coding procedures
- review patient's medical data
- use clinical assessment techniques
- use foreign languages for health-related research
知识
可选技能和知识（31）
技能与能力
- advise on training courses
- communicate in foreign languages with health service providers
- comply with legislation related to health care
- implement strategic planning
- inform policy makers on health-related challenges
- manage budgets
- manage project metrics
- manage workflow processes
- meet deadlines
- participate in medical records' auditing activities
- perform project management
- recruit employees
- supervise staff
- train employees
知识
- IBM InfoSphere DataStage
- IBM InfoSphere Information Server
- Informatica PowerCenter
- Oracle Data Integrator
- Oracle Warehouse Builder
- Pentaho Data Integration
- QlikView Expressor
- SAP Data Services
- SQL Server Integration Services
- analytical methods in biomedical sciences
- audit techniques
- conditions for professional practice of clinical psychology
- creation of clinical psychological opinions
- data extraction, transformation and loading tools
- health psychology
- healthcare analytics
- manage healthcare staff
regulatory affairs manager
Regulatory affairs managers are in charge of regulatory and legal affairs in several sectors such as the healthcare, energy and banking industries. They oversee the development of products and services from inception to market release by making sure everything complies with the local legislation and meets regulatory requirements. They have experience in the different phases of regulatory processes and act as an interface between business and government legislation or regulatory boards.
必备技能和知识（26）
技能与能力
- advise on efficiency improvements
- analyse legislation
- comply with legal regulations
- develop company strategies
- develop licensing agreements
- develop organisational policies
- enforce financial policies
- ensure compliance with company regulations
- ensure compliance with legal requirements
- ensure compliance with policies
- ensure products meet regulatory requirements
- identify legal requirements
- implement strategic planning
- integrate strategic foundation in daily performance
- interpret technical requirements
- manage relationships with stakeholders
- meet the requirements of legal bodies
- monitor company policy
- monitor compliance with licensing agreements
- organise business documents
- prepare licence agreements
知识
可选技能和知识（25）
技能与能力
- advise on legal decisions
- analyse legal enforceability
- analyse scientific data
- communicate with banking professionals
- contact scientists
- identify hazards in the workplace
- keep updated on innovations in various business fields
- protect personal data and privacy
- provide legal advice
- support managers
知识
- banking activities
- copyright legislation
- corporate law
- corporate social responsibility
- financial jurisdiction
- financial products
- hazard analysis and critical control points
- intellectual property law
- international trade
- law enforcement
- nuclear legislation
- patents
- procurement legislation
- quality standards
- tax legislation
Contains ESCO v1.2.1 data (https://esco.ec.europa.eu/). © European Union. Reuse authorised under Commission Decision 2011/833/EU.