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Clinical Safety Officer

2 months ago

United Kingdom The AbedGraham Group Full time

Job Role Overview

Clinical Safety Officer - This opening is to join one of the foremost strategy, risk and compliance providers in the UK. We are looking for an experienced Clinical Safety Officer (CSO) to support our growing international client base.

About The AbedGraham Group

Established over a decade ago, The AbedGraham Group has grown in to one of the most trusted consultancies for technology companies and government agencies. We provide a range of strategic, marketing, project management and compliance services for health IT, security, medical device and network infrastructure vendors. Within our compliance service set, we provide DCB0129, Digital Technology Assessment Criteria (DTAC), Data Security and Protection toolkit (DSPT) and cybersecurity services for dozens of the industry’s leading companies.

About the Job

The job role is to join the compliance team at The AbedGraham Group in the capacity of Clinical Safety Officer. Within the NHS, all suppliers of digital technologies that impact patient care are obliged to comply with the mandatory DCB0129 standard and complete DTAC submissions for review by purchasing organisations or regulators. The AbedGraham Group assists dozens of companies with these processes and frequently acts as the Clinical Safety Officer on their behalf. You will be working under the COO to help maintain existing clients’ compliance and ensuring new clients’ requirements are met. Our compliance work extends across a huge range of specialties from primary to secondary to community and mental health care and across dozens of healthcare IT verticals including EHR, document management, radiology, psychiatry, remote monitoring, online and video consultations, community testing, speech recognition and digital dictation, genomics and surgery.

Essential Requirements

  • A registered clinician with a UK professional body with at least 2 years’ experience
  • An approved Clinical Safety Officer (that is either evidence of NHS Digital’s risk course attendance or a similar accreditation)
  • At least 2 years’ experience in either creating or reviewing the standard documents within DCB0129 (clinical safety case report, hazard log, clinical risk management plan/system)
  • Knowledge of clinical informatics and its application in multiple healthcare environments
  • Knowledge of ongoing compliance requirements (software testing, release reviews, incident management)
  • Exceptional communication and documentation skills
  • Exceptional productivity and efficiency

Desirable Requirements

  • Experience with companies who have Artificial Intelligence (AI) as part of their product set
  • Knowledge or experience of medical device regulations including ISO13485 and ISO14971
  • Knowledge or experience of deploying healthcare technologies in line with DCB0160 best principles
  • Knowledge of wider DTAC competencies (security, data protection, interoperability)
  • Experience in or working with NHS Digital or regional/national procurements/rollouts
  • Experience with medical device regulation

The Offer

  • Fully remote working
  • Competitive Salary
  • Up to 10% bonus annually
  • Private healthcare cover
  • Company pension
  • All professional training/accreditation requirements and costs covered
  • All IT requirements and costs covered

Finally the opportunity for job growth is important to us. The right candidate can expect the responsibility of managing our clients’ work themselves as well as overseeing the work of others in due course. A more strategic role, reporting to the executive board, will also be considered after 12 months. Please send all submissions and CVs to agraham@abedgraham.com, we look forward to speaking with you and for you to join us on this exciting journey