(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

• Assuring compliance with applicable standard operating procedures, work instructions, guidelines and regulatations
• Managing adverse events/ device deficiencies from recording in electronic case report form (eCRF) until completion
• Assuring compliance and adherence to adverse event reporting requirements
• Authoring periodic safety reports to authorities, relevant sections in clinical investigation plan, and data monitoring committee charter
• Collaborating with clinical data operations team, clinical project management team, and monitors
• Initiating, managing, monitoring collaboration with Contract Research Organizations / Consultants
• Representing the Clinical Safety & HEOR Team in assigned (study) core team meetings, and meetings with Medical Affairs and within the company
• Training of internal and external study team members
• Ensuring compliance with corporate values

Your Profile

• University degree or equivalent in medical sector. Alternatively medical background (e.g., nurse, cath-lab technician)
• Team player with strong people skills: Verbal communication, listening, proactive, conflict resolution, diplomacy, decision making and collaboration
• Personal skillset ideally includes strong troubleshooting, organisation/planning & time management, service orientation, work ethics, taking ownership, attention to detail
• Understanding of ISO 14155:2020/2024, Medical Device Regulation (MDR, 2017/745) and Medical Device Coordination Group 2020-10/1 requirements
• Language skills: English, fluent both written and spoken; German, basic understanding both written and spoken
• Computer skills in Microsoft Office word processing, presentation, and calculation software, eCRF, clinical trial management system, electronic trial master file

Please apply online via our application management system. We are looking forward to talking to you!

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

Job ID: 60621 | Contact: Martina Micciulla | Tel. +41 75 429 56 23