Safety Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Safety Associate based in United States.

This remote role supports the delivery of high-quality 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 related study safety <activities.You> will collaborate with sponsors, study teams, regulatory stakeholders, and internal experts to maintain data quality and compliance.The role combines hands-on safety case processing with quality assurance, documentation, reporting, and process <improvement.You> will work in a collaborative, detail-oriented environment where sound 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 outcomes.

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 action items and minutes.

Co-author and maintain study-specific safety documents such as Safety Plans, CEC Charters, and DMC Charters, ensuring activities remain aligned with protocols and established requirements.

Prepare aggregate safety reports and support submission of final reports to regulatory authorities or sponsors.

Monitor departmental performance and quality indicators, maintain tracking tools, and consistently meet established quality and productivity targets.

Contribute to the development and maintenance of standard operating procedures, guidelines, templates, training materials, and safety-related documentation.

Participate in quality control and quality 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 quality 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 current knowledge of Good Clinical Practices, Good Vigilance Practices, medical terminology, safety writing standards, data-entry conventions, and relevant safety processes.

Independently prioritize workloads, provide project status updates, track action items, and support operational improvements with minimal management direction.

Serve as a mentor and resource for less experienced safety professionals and non-safety colleagues.

Support invoicing activities and resolve billing questions related to safety services in collaboration with Finance.

Perform additional safety-related responsibilities and project support as assigned.

Requirements

Bachelor's degree from a four-year college or university in Life Sciences or a related 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 (EDC) 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 quality.

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 a team environment while maintaining a professional and service-oriented approach.

Proficiency with Microsoft Office applications, particularly Outlook, Word, and Excel.

Ability to learn and effectively use a range of software applications, computerized systems, EDC 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 sound judgment and maintain confidentiality when handling sensitive clinical and safety information.

Benefits

• Salary range: $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.
• Collaborative environment with opportunities to work across safety, clinical research, regulatory, quality, sponsor, and operational teams.
• Opportunities to develop expertise in safety reporting, clinical events adjudication, data monitoring, and related clinical research processes.
• Exposure to industry standards and practices including Good Clinical Practices and Good Vigilance Practices.
• Reasonable accommodations are available for qualified individuals with disabilities.
• Equal employment opportunity and a commitment to a respectful, collaborative, and inclusive workplace.
• Pre-employment background and drug screening may apply in accordance with applicable laws.