(Senior) Clinical Safety Officer
Biotronik
- Bülach, Zürich
- Unbefristet
- Vollzeit
- Working according to assigned SOP and WIs
- Reviewing and assessing adverse events and requesting, if indicated, (additional) source documents
- Reporting of adverse events according to guidelines and regulations, and assuring compliance with reporting timelines
- Preparing adverse events for the Clinical Event Committee (CEC) adjudication process and clarifiy case related issues with CEC members
- Preparing and authoring safety reports for EC/CA reporting
- Contributing to the device deficiency evaluation process and responsible to assure compliance in reporting requirements
- Ensuring compliance with corporate values
- University degree or equivalent in medical or scientific discipline. Alternatively excellent medical background (e.g., nurse, cath-lab technician)
- Experience in safety reporting to authorities for Class III medical devices or alternatively experience in clinical trial management or vigilance reporting
- Sound knowledge of ISO 14155:2020, Medical Device Regulation (MDR, 2017/745) and Medical Device Coordination Group 2020-10/1 statement
- Excellent command of spoken and written English, and a good level of German (B1)
- Team player with strong people skills: Verbal communication, listening, proactive, conflict resolution, diplomacy, decision making and collaboration
- Personal skillset includes strong troubleshooting, organisation/planning & time management, service orientation, work ethics, taking ownership, attention to detail
- Computer skills in Microsoft Office (MS365) applications and electronic case report form (eCRF)
- Skills in programming language such as Python, R, MATLAB are an asset