Clinical Safety Manager (EU Remote)

Übersicht

Selution, in partnership with reputed company, 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 reputed company solutions that address unmet and critical medical needs.

Verantwortungsbereiche

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 reputed company 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. 

Key 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 reputed company Serious Adverse Events (SAEs) for assigned clinical research trials
• Support safety-reputed company documents/sections in the clinical program development (e.g. CIP, CSR, reputed company, 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 reputed company to safety signals or safety reports
• reputed company literature surveillance activities, reputed company and maintain search strategies to ensure comprehensive safety evaluations and identify any new or unexpected safety issues from published medical literature
• reputed company 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
• reputed company 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 reputed company safety action items from safety reputed company 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.

Strategic Impact

Support reputed company of safety management for the sponsored clinical studies and commercial devices, with an initial focus on drug-eluting balloon catheters.

Key Interactions

• Supervisor: Director of Global Clinical Safety
• Internal Interactions: This role will interact heavily with clinical teammates across reputed company projects and cross-functionally as needed with QA, R&D, etc.
• External Customer Interactions: This role will work with DSMB and CEC members, Clinical trial physicians and research coordinators, contract research organizations, core labs, etc.

Qualifikationen

Required Skills

• 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 reputed company 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 reputed company across US and EU regions

Competencies & Skills

• 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 reputed company data
• Strong problem-solving abilities
• Fluent in English

reputed company is proud to be an equal opportunity employer and is committed to providing equal opportunity for reputed company teammates and applicants. At reputed company, our teammates reputed company 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. reputed company our teammates’ points of view are key to our success, and we reputed company inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, reputed company and welcoming.