(Senior) Clinical Safety Officer

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Medical Affairs Group with BIOTRONIK AG in Bülach, Zürich is responsible for the design, conduction and evaluation of international first-in-men, regulatory submission and post-marketing trials as well as investigator-initiated trials. The Safety Group is responsible for the review, assessment, and reporting of adverse events from clinical trials to European and international Competent Authorities and Ethics Committees according to their specific requirements.

Your Responsibilities

• Working according to assigned SOP and WIs
• Reviewing and assessing adverse events and requesting, if indicated, (additional) source documents
• Reporting of adverse events accordingto guidelines and regulations, and assuringcompliance with reporting timelines
• Preparing adverse events for the Clinical Event Committee (CEC) adjudication process andclarifiy 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

Your Profile

• University degree or equivalent in medical or scientific discipline. Alternatively excellent medical background (e.g., nurse, cath-lab technician)
• Experience in safety reporting toauthorities for Class III medical devicesor 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

Please apply online viaour application management system.We are looking forward to talking toyou!

Location: Bülach, Zürich | Working hours: Full-time | Type of contract: Unlimited

Apply now: www.biotronik.com/careers

Job ID: 58874 |Contact: Martina Micciulla| Tel.+41 75 429 56 23