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작업 내용

(Associate) Clinical Safety Officer (m/f)


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


  • Reporting of adverse events acc. to guidelines and regulations following country specific requirements and assure compliance with reporting timelines
  • Managing/maintaining clinical events committee (CEC) adjudications in compliance with guidelines and regulations
  • Reviewing and assessing adverse events and requesting, if indicated, (additional) source documents
  • Preparing adverse events for the adjudication process and clarify case related issues with CEC members
  • Preparing and writing periodic safety reports for EC/CA reporting, including following up until “closure” of adverse events per local requirements and within given timeframes to competent authorities, in collaboration with a senior member
  • Contributing to the device deficiency evaluation process and responsible to assure compliance in reporting requirements

Your Profile


  • University degree or equivalent experience and/or background in medical, pharmaceutical or veterinary sciences field required, alternatively excellent medical background (e.g. nurse, cath-lab technician)
  • Experience in safety reporting with authorities preferably in medical devices (Class III) or alternatively experience in clinical trials, vigilance reporting, or post market surveillance
  • Knowledge of ISO 14155, medical device regulation MDR and MDCG 2020-10/1
  • Excellent command of spoken and written English and German, all other languages are an asset
  • Good skills in word processing, presentation, and calculation software (i.e. MS Office)
  • Team player with strong people skills: Verbal communication, listening, proactive, conflict resolution, diplomacy, decision making and collaborating
  • Personal skillset ideally includes strong troubleshooting, organisation/planning & time management, service orientation, work ethic, taking ownership, attention to detail

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

Apply now: www.biotronik.com/careers

Job ID: 42321 | Contact: Juliane Sasse


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

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마감 시간: 10-05-2024

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