Clinical Safety Manager (East Coast Remote)

Cordis•Irvine, CA

13h•$114,950 - $165,000•Remote

About The Position

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 U.S. East Coast (EST) or European Union based Clinical Safety Manager 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 Manager 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.

Requirements

Master’s or PhD in relevant Scientific field, or equivalent
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.
Safety management experience on US IDE trials
Proficiency with MedDRA (or IMDRF) and experience in safety signal detection and risk management.
Experience in safety data analysis, including analyzing trends and patterns in large datasets.
Solid understanding of FDA, ICH, GCP, SAE reporting and other global medical device regulations and safety reporting requirements.
Experience with safety reporting, guidelines, compliance and oversight across US and EU regions
Precise, rigorous, detail-oriented with strong work ethic
Excellent communication, writing and listening skills
Demonstrates strong ability to communicate effectively cross functionally
Exhibits ability to multi-task effectively
Demonstrates solid project management skills and strong attention to detail
Self-driven and motivated
Ability to analyze, interpret, and summarize complex data
Strong problem-solving abilities
Fluent in English

Responsibilities

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.
Investigate, manage and process all Serious Adverse Events (SAEs) for assigned clinical research trials
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.
Support safety responses to address any regulatory queries or concerns related to safety signals or safety reports
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
Lead regular safety review meetings and contribute to discussions on safety data interpretation, safety signal assessment and risk mitigation strategies.
Generate safety narratives for Adverse Event (AE) cases as required
Create Safety Plans as applicable
Develop DSMB and CEC charters
Oversees timelines for adverse event processing, reviews summary safety data at regular intervals and monitors CEC adjudication results.
Monitor and track all safety action items from safety oversight committees (CEC and DSMB) to ensure timely implementation of any risk mitigation strategy
Support data review and presentation development for data monitoring committee meetings
Contribute to the coding of events according to MedDRA or IMDRF standards.
Manage the monitoring and reporting of personal data breaches (PHI), in compliance with applicable regulations (HIPAA, GDPR)
Contribute upon request to safety documentation for marketed devices: clinical data reviews, periodic safety update reports, etc.
Support oversight of safety management for the sponsored clinical studies and commercial devices, with an initial focus on drug-eluting balloon catheters.