Clinical Safety Officer

Position Summary

The Medical Affairs Group with Teleflex 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.

Principal 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

Education / Experience Requirements

• University degree or equivalent in medical sector. Alternatively medical background (e.g., nurse, cath-lab technician)
• Previous experience as a Safety Officer, Clinical Safety Specialist, or in medical device safety/pharmacovigilance is highly desirable and will be considered an advantage
• 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

What we offer

• Flexible working hours
• Mobile Working up to 40%
• At least 25 days of holidays
• Friday after Ascension is a paid absence day
• Training and further development opportunities
• Company canteen with various options
• Discounts for public transportation or affordable parking options