Clinical Safety Reporting Specialist
Cook Medical is looking for a Clinical Safety Reporting Specialist. You will be responsible for reporting adverse events and device issues occurring within clinical studies to regulatory authorities in compliance with regulatory requirements or to Cook manufacturers for potential post-market reporting.
- Generate and submit appropriate regulatory reports for investigational studies
- Develop and maintain a working knowledge of local and global regulatory requirements and standards (e.g., FDA CFR, ISO 14155, MDD/EU-MDR) that impact device studies, especially relating to adverse event reporting
- Review regulatory responses to reports and submit follow-up information as needed
- Develop and maintain a working knowledge of the process for local/regional regulatory reporting related to investigational and post-market studies
- Collaborate with study teams to determine if adverse events meet reporting requirements for investigational studies
- Collaborate with study teams and local/global regulatory affairs personnel to determine if adverse events meet reporting requirements for post-market studies
- Follow established procedures for Cook manufacturers’ complaints database entry, investigation, and closure
- Collaborate with local and global Cook regulatory affairs personnel to assure consistency in reporting while meeting regulations that govern both study reporting requirements and manufacturers’ reporting requirements
- Provide input to adverse event requirements for the development of CIPs, CRFs, EMPs, Progress Reports, etc.
- Ensure that adverse event reporting activities comply with quality system procedures, applicable standards, and clinical systems
- Review and update quality system procedures on adverse event reporting to comply with regional regulatory requirements and train relevant personnel
- Relevant ad hoc tasks
- Bachelor of Science in nursing or similar clinical degree or previous experience of regulatory reporting required (or equivalent in local region)
- Knowledge of clinical research regulations desirable
- Experience of clinical research trials preferred
- Demonstrated clinical knowledge to accurately assess and interpret clinical data
- Excellent verbal and written communication skills in English and Danish
Cook Medical’s company culture is based on a set of strong, common values where responsible, competent and professional employees are our most important resource.
We have a flat organizational structure and focus on open dialog. Qualities, such as determination, loyalty and humor are highly appreciated. The staff of Cook Medical helps to uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide – every day, we make a difference.
In addition to a salary package with pension, we offer flextime, a bonus system, health insurance, as well as free use of the company’s own training facilities.
For further information, please contact Maja Skytte Jensen, Director of Clinical Affairs, EMEA at +45 23282338.
Deadline for applications is October 13, 2019.