Overview:
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.
Responsibilities:
We are seeking a highly skilled Senior Clinical Safety Specialist with global pre-market and post-market study expertise in cardiovascular medical devices. This 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 Sr. Specialist will be responsible for review, evaluation, and analysis of safety events and information from ongoing clinical studies, supporting clinical and regulatory activities across several clinical studies.
Key Responsibilities
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Continuously review and analyze adverse events and safety data 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.
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Investigate, manage and process all Serious Adverse Events (SAEs) for assigned clinical research trials
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Support safety-related documents/sections in the clinical program development (e.g. CIP, CSR, ICF, IB, etc.)
- Review, or prepare and submit, safety reports to regulatory agencies (individual or summary reports), in compliance with applicable country regulatory requirements and guidelines.
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Support safety responses to address any regulatory queries or concerns related to safety signals or safety reports
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Perform literature surveillance activities, develop and maintain search strategies to ensure comprehensive safety evaluations and identify any new or unexpected safety issues from published medical literature
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Support regular safety review meetings and contribute to discussions on safety data interpretation, safety signal assessment and risk mitigation strategies.
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Generate safety narratives for Adverse Event (AE) cases as required
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Create Safety Plans as applicable
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Develop DSMB and CEC charters
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Oversees timelines for adverse event processing, reviews summary safety data at regular intervals and monitors CEC adjudication results.
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Monitor and track all safety action items from safety oversight committees (CEC and DSMB) to ensure timely implementation of any risk mitigation strategy
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Support data review and presentation development for data monitoring committee meetings
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Contribute to the coding of events according to MedDRA or IMDRF standards, or review of coding.
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Manage the monitoring and reporting of personal data breaches (PHI), in compliance with applicable regulations (HIPAA, GDPR)
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Contribute upon request to safety documentation for marketed devices: clinical data reviews, periodic safety update reports, etc.
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Strategic Impact
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Support oversight of safety management for the sponsored clinical studies and commercial devices, with an initial focus on drug-eluting balloon catheters.
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Supervisor: Director of Global Clinical Safety
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Internal Interactions: This role will interact heavily with clinical teammates across all projects and cross-functionally as needed with QA, R&D, etc.
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External Customer Interactions: This role will work with DSMB and CEC members, Clinical trial physicians and research coordinators, contract research organizations, core labs, etc.
Qualifications:
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Master’s or PhD in relevant Scientific field, or equivalent
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Minimum of 4 years of relevant experience in clinical safety with global pre-market and post-market clinical trial experience within the cardiovascular medical device industry.
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Safety management experience on US IDE trials
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Proficiency with MedDRA (or IMDRF) and experience in safety signal detection and risk management.
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Experience in safety data analysis, including analyzing trends and patterns in large datasets.
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Solid understanding of FDA, ICH, GCP, SAE reporting and other global medical device regulations and safety reporting requirements.
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Experience with safety reporting, guidelines, compliance and oversight across US and EU regions
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Precise, rigorous, detail-oriented with strong work ethic
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Excellent communication, writing and listening skills
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Demonstrates strong ability to communicate effectively cross functionally
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Exhibits ability to multi-task effectively
- Demonstrates solid project management skills and strong attention to detail
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Self-driven and motivated
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Ability to analyze, interpret, and summarize complex data
- Strong problem-solving abilities
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Fluent in English
Preferred Qualifications:
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.
