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Holly Ankjell is a seasoned healthcare professional with extensive experience in clinical research, project management, and quality improvement. She holds a Master's degree in Quality Improvement in Healthcare from the University of Wales, Swansea, and a Bachelor's degree in Psychology from the University of Northumbria at Newcastle. With over 20 years of experience in the pharmaceutical industry, healthcare, and research, she has developed a strong skill set in clinical research, project management, and quality improvement. She is proficient in multiple languages, including English and Norwegian.

Experience

    • Produktansvarlig Velferdsteknologi Applikasjonen
      • Sep 2022 - Present
      • Oslo, Oslo, Norge

    • Rådgiver klinisk IKT - Avdeling for IKT og eHelse
      • Feb 2020 - Oct 2022
      • Oslo, Norway

    • Spesialrådgiver eHelse - Special Advisor for eHealth
      • May 2013 - Jan 2020
      • Oslo, Norway

  • GE Healthcare
    • Oslo, Norway
    • Safety Coordinator, Drug Safety Surveillance Department
      • Sep 2006 - Apr 2013
      • Oslo, Norway

      Aug 2011 - April 2013:European functional lead for an IT project to automate reporting of serious adverse drug reactions directly from the department's global pharmacovigilance database (ARISg) to Regulatory Authorities. Key tasks - ARISg System administrator. Specification of functionality. Creation of test scripts to meet Regulatory Authorities' exacting requirements. System testing, documented in HP Quality Center. Trained two co-testers. Analysis and resolution of failed tests, in collaboration with project team members, system developers and test reviewers from the Regulatory Authorities. Updated the ARISg User Manual, and wrote and presented training materials. Daily communication with team members in India and the USA. Mar - Jul 2012:Project Manager - xEVMPD project. Engaged project team (Pharmacovigilance, Regulatory Affairs, IT) to review vendor proposals and idenify a preferred provider. Managed the outsourcing of this work, ensuring that the project was successfully completed on time and within budget.Key tasks - Vendor selection. Presentation of vendor review to senior management. Contract negotiations. xEVMPD certificated training. Registration with EMA. Established project infrastructure. Reviewed project progress, highlighted risks, escalated issues. Sep 2006 - Jul 2011:Responsible for the coordination and handling of all incoming and outgoing adverse reaction notifications, arising from the use of GE Healthcare's contrast media products worldwide. Responsible for ensuring that the distribution of Individual Case Safety Reports (ICSRs) and SUSARs is in compliance with pharmacovigilance regulations. Key tasks - Receipt, assessment and triage of incoming adverse events from all sources. Identification and follow up of missing or inconsistent case information. Registration and full data entry of adverse event reports, including MedDRA coding and preparation of case narratives. Assessment of reportability.

  • NHS Lanarkshire
    • Coatbridge, Lanarkshire, Scotland
    • Clinical Governance Coordinator, Adult Mental Health Services
      • Feb 2003 - Jun 2006
      • Coatbridge, Lanarkshire, Scotland

      Member of the Clinical Management Team, working with health service staff to help them to improve the quality of the service / care provided. Role involved working with staff of all disciplines and seniority. Educating and engaging staff in quality improvement techniques, fostering a culture of reflective practice. Main duties included service development projects, undertaking audits and report writing. Excellent leadership, communication and engagement skills were required. • Experience of inspections from national regulatory authorities – NHS Quality Improvement Scotland (NHS QIS).• Completed a six day leadership course in 2003• Developed project management, presentation and group facilitation skills.

  • King's College London
    • London, England
    • Research Assistant, Psychology and Genetics Research Group
      • Jun 2001 - Jan 2003
      • London, England

      Member of the evaluation team for the national Newborn Hearing Screening Programme. Responsible for the development and daily management of two research studies exploring levels of maternal anxiety and satisfaction with the new screening programme. • Experience of a national qualitative research project from A to Z – incorporating literature search and appraisal, pilot testing at Whipps Cross Hospital in East London, development of study material, ethics approval, database design (Microsoft Access), data entry and analysis (SPSS), report writing, publication and presentations at national conferences (Microsoft Powerpoint).• Travelled around the UK visiting pilot sites. Attended project meetings, updated staff on the progress of the project, and conducted staff training.• Three publications, including one as first author (Maiden name Baker)Bamford, J., Ankjell, H., Crockett, R., Marteau, T., McCracken, W., Parker, D., Tattersall, H., Taylor, R., Uus, K. and Young, A.Evaluation of the Newborn Hearing Screening Programme in England: Studies, Results and Recommendations.Report to the Department of Health. May 2005.Crockett, R., Baker, H., Uus, K., Bamford, J. and Marteau, T.Maternal anxiety and satisfaction following infant hearing screening: a comparison of the health visitor distraction test and newborn hearing screening.Journal of Medical Screening, 2005: 12(2) 78-82.Baker, H., Uus, K., Bamford, J. and Marteau, T.Increasing knowledge about a screening test: Preliminary evaluation of a structured, chart-based, screener presentation.Patient Education and Counselling, 52 (2004) 55-59

    • Research Assistant, Research Division
      • Nov 1999 - May 2001
      • London, England

      Responsible for the daily running of a national research project, studying the screening and treatment of Stage 3 Retinopathy of Prematurity in the UK. Also managed the UK Glactosaemia register and assisted the Research Officer with the development and establishment of a Severe Fatigue Syndrome research project.Haines, L., Fielder, AR., Baker, H. and Wilkinson, AR.UK population based study of severe retinopathy of prematurity: screening, treatment and outcome.Archives of Disease in Childhood – Fetal Neonatal Ed. 2005; 90: F240-F244.

  • NHS Surrey and Borders Partnership
    • St. Ebbas Hospital, Epsom, Surrey, England
    • Assistant Clinical Psychologist
      • Oct 1997 - Oct 1999
      • St. Ebbas Hospital, Epsom, Surrey, England

      N.B. Company name 'Surrey Oaklands NHS Trust' at time of employment.Joint manager of a project to develop a day service for twelve people with autism, severe learning disabilities and challenging behaviour. Under direct supervision of a doctor of clinical psychology undertook extensive clinical assessments of all 12 service users, such that the day service could be taylored exactly to each individuals needs.

  • The Children's Trust, Tadworth
    • Tadworth, Surrey, England
    • Rehabilitation / Research Assistant, Acquired Brain Injury Unit
      • Aug 1996 - Sep 1997
      • Tadworth, Surrey, England

      Worked on the rehabilitation unit for children with acquired brain injury. Role involved caring for the children on a 1:1 basis, supporting them with all activities of daily living and their rehabilitation programme.

Education

  • 2003 - 2008
    University of Wales, Swansea
    Master's degree, Quality Improvement in Healthcare
  • 1993 - 1996
    University of Northumbria at Newcastle
    Bachelor's degree (BSc), Psychology

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