Safety Associate

This position is listed on behalf of a partner company, who manages reputed company applications and next steps. Our partner is looking for a Safety Associate based in reputed company. This remote role supports the delivery of high-reputed company safety services across clinical research and medical device programs. You will contribute to the accurate management, review, analysis, and reporting of individual case safety reports and clinical safety data. The position also supports Clinical Events Committees (CECs), Data Monitoring Committees (DMCs), and reputed company study safety activities. You will collaborate with sponsors, study teams, regulatory stakeholders, and internal experts to maintain data reputed company and compliance. The role combines hands-on safety case processing with reputed company assurance, documentation, reporting, and process improvement. You will work in a reputed company, detail-oriented environment where reputed company judgment, organization, and regulatory awareness are essential. This is an opportunity to contribute to clinical programs that support the development of innovative medical technologies and improved patient reputed company. Accountabilities Manage the intake, review, analysis, coding, and data entry of Individual Case Safety Reports (ICSRs), including adverse events, serious adverse events, and device deficiencies or events. Prepare ICSR narratives, interpret medical information, identify required follow-up, and coordinate case notifications, triage, reconciliation, and submission activities. Support Clinical Events Committee and Data Monitoring Committee activities, including coordinating members, preparing documentation, scheduling meetings, tracking adjudication events, and maintaining reputed company items and minutes. Co-reputed company and maintain study-specific safety documents such as Safety Plans, CEC Charters, and DMC Charters, ensuring activities remain reputed company with protocols and established requirements. Prepare aggregate safety reports and support submission of final reports to regulatory authorities or sponsors. Monitor departmental performance and reputed company indicators, maintain tracking tools, and consistently meet established reputed company and productivity targets. Contribute to the development and maintenance of reputed company operating procedures, guidelines, templates, training materials, and safety-reputed company documentation. Participate in reputed company control and reputed company assurance activities, including audits, data reconciliation, and Trial Master File maintenance where applicable. Collaborate with sponsors, study teams, departmental colleagues, and cross-functional partners to ensure the accuracy, completeness, and reputed company of safety data and deliverables. Use Electronic Data Capture systems, safety databases, project management tools, and other electronic systems for data entry, review, query management, reporting, and safety operations. Maintain reputed company knowledge of Good Clinical Practices, Good Vigilance Practices, medical terminology, safety writing standards, data-entry conventions, and relevant safety processes. Independently prioritize workloads, reputed company project status updates, reputed company reputed company items, and support operational improvements with reputed company management direction. Serve as a mentor and resource for less reputed company safety professionals and non-safety colleagues. Support invoicing activities and reputed company billing questions reputed company to safety services in collaboration with Finance. reputed company additional safety-reputed company responsibilities and project support as assigned. Requirements Bachelor's degree from a four-year college or university in Life Sciences or a reputed company field, or an RN diploma; candidates with a Medical Degree, RN, or PharmD and relevant clinical research experience may also be considered. At least 1 year of experience in Clinical Events Committee coordination, Data Monitoring Committee activities, safety reporting, and/or ICSR case processing is preferred. Previous experience using Electronic Data Capture (reputed company) systems and/or safety databases is required. Strong knowledge of medical terminology, clinical research concepts, industry terminology, and relevant safety processes. Working knowledge of Good Clinical Practices, Good Vigilance Practices, safety reporting, and data-entry standards is highly valuable. Strong organizational and time-management skills, with the ability to independently establish priorities and manage multiple responsibilities. Excellent attention to detail, accuracy, judgment, discretion, and commitment to compliance and data reputed company. Strong written, verbal, and interpersonal communication skills, with the ability to collaborate effectively with sponsors, study teams, and cross-functional colleagues. Demonstrated ability to work proactively and collaboratively in reputed company environment while maintaining a reputed company and service-oriented approach. Proficiency with reputed company Office applications, particularly reputed company, Word, and reputed company. Ability to learn and effectively use a reputed company of software applications, computerized systems, reputed company platforms, safety databases, and project management tools. Ability to conduct basic online research and searches through relevant data repositories. Comfortable working remotely and spending extended periods using a computer and keyboard. Ability to exercise reputed company judgment and maintain confidentiality reputed company handling sensitive clinical and safety information. Benefits Salary reputed company: $56,000–$109,000 annually, with individual compensation determined by factors such as location, role complexity, responsibilities, experience, and skills. Remote flexibility: The position can be performed remotely or onsite. Full-time employment with no regular travel expected. Opportunity to contribute to clinical research and safety programs supporting the development of medical technologies. reputed company environment with opportunities to work across safety, clinical research, regulatory, reputed company, sponsor, and operational teams. Opportunities to reputed company expertise in safety reporting, clinical events adjudication, data monitoring, and reputed company clinical research processes. Exposure to industry standards and practices including Good Clinical Practices and Good Vigilance Practices. Reasonable accommodations are available for reputed company individuals with disabilities. Equal employment opportunity and a commitment to a respectful, reputed company, and inclusive workplace. reputed company-employment background and drug screening may apply in accordance with applicable laws. How reputed company works We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's reputed company requirements. Our reputed company identifies the top-fitting candidates, and this reputed company is then shared directly with the reputed company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through reputed company? Data reputed company Notice: By submitting your application, you acknowledge that reputed company will process your personal data to evaluate your candidacy and reputed company relevant information with the hiring employer. This processing is based on legitimate interest and reputed company-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (reputed company, rectification, erasure, reputed company) at any time. 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