Clinical safety officer
Clinical safety officers are registered clinicians who make sure the health IT systems the organization builds, buys, and deploys are safe for patients. They run the clinical risk management process, lead hazard identification, own hazard logs, and write and sign off clinical safety case reports, using clinical risk management standards such as ISO 14971 and IEC 80001-1.
- UK GDaD PCF role
- None: this reference defines the role
- ESCO occupations
- clinical informatics manager (ISCO-08 1342); regulatory affairs manager (ISCO-08 2619)
- On GitHub
- Role document · Role data
Levels
| Band | Role level | UK GDaD PCF level | Civil Service grades | Job evaluation points |
|---|---|---|---|---|
| 7 | Clinical safety officer | — | — | 522 |
| 8a | Senior clinical safety officer | — | — | 577 |
| 8b | Head of clinical safety | — | — | 619 |
In a digital health care organization
- The role must be held by a registered clinician, so that safety judgments rest on current clinical knowledge and professional accountability.
- Health IT can harm patients through wrong, missing, delayed, or misleading information, so the role assesses risks that are often hidden in data and workflows.
- Clinical safety work runs through the whole life of a system, from design and procurement to deployment, change, and decommissioning.
- Some products are also regulated as medical devices, so the role works with regulatory and quality colleagues where safety cases and device files overlap.
- Safety incidents involving health IT may cause serious harm, so the role investigates incidents and makes sure lessons are learned.
ESCO occupations and skills
ESCO lists the skills and knowledge that employers usually need (essential) or may need (optional) for each occupation. Use them as a checklist for development conversations.
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.
Essential skills and knowledge (28)
Skills and competences
- 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
Knowledge
Optional skills and knowledge (31)
Skills and competences
- 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
Knowledge
- 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.
Essential skills and knowledge (26)
Skills and competences
- 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
Knowledge
Optional skills and knowledge (25)
Skills and competences
- 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
Knowledge
- 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.