Clinical Safety Manager (EU Remote)

Clinical Safety Manager

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

We are seeking a highly skilled Clinical Safety Manager with global pre-market and post-market study expertise in cardiovascular medical devices. This remote-based EU role is pivotal in ensuring timely review, identification and communication of safety signals for drug eluting balloons and contributing to the execution of our clinical investigations in conformity with all applicable requirements and standards.

The Clinical Safety Manager will be responsible for review, evaluation, and analysis of safety events and information from ongoing clinical studies to monitor and identify any emerging safety signals or trends, potential risks, or emerging safety issues associated with the investigational products. This role will also support safety-related documents/sections in the clinical program development, review, or prepare and submit safety reports to regulatory agencies, and perform literature surveillance activities to ensure comprehensive safety evaluations.

Key responsibilities include leading regular safety review meetings, generating safety narratives for adverse event cases, developing safety plans, overseeing timelines for adverse event processing, and monitoring and tracking all safety action items from safety oversight committees.

This role will interact heavily with clinical teammates across all projects and cross-functionally as needed with QA, R&D, etc. It will also work with DSMB and CEC members, clinical trial physicians and research coordinators, contract research organizations, core labs, etc.

Required skills include a Master's or PhD in a relevant scientific field, minimum of 5 years of relevant experience in safety surveillance with global pre-market and post-market clinical trial experience within the cardiovascular medical device industry, proficiency with MedDRA and experience in safety signal detection and risk management, and a solid understanding of FDA, ICH, GCP, SAE reporting and other global medical device regulations and safety reporting requirements.

Competencies and skills include being precise, rigorous, detail-oriented with a strong work ethic, excellent communication, writing and listening skills, the ability to communicate effectively cross functionally, the ability to multi-task effectively, solid project management skills, and strong attention to detail.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammates' points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.