MedTech Safety Operations Lead

IQVIA Argentina; Washington (District of Columbia); On-site; USD 52,000 - 130,000; Full time

Job summary

IQVIA is seeking a MedTech Safety Project Lead to provide operational, project coordination, and administrative support to the Clinical Safety team across clinical and post-market safety programs.

The role coordinates safety projects, committees (CECs, DSMBs), and documentation, ensuring timely deliverables, compliance with FDA/EU MDR/ISO standards, and collaboration across Clinical Operations, Regulatory Affairs, Quality, and Medical Affairs.

Qualifications

• Bachelor’s degree in a health-related field.
• Minimum 2 years of clinical, healthcare, clinical research, medical device, or patient care experience.
• Strong organizational and time-management skills.
• Excellent verbal and written communication.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Detail-oriented with accurate documentation practices.

Responsibilities

• Provide day-to-day operational and administrative support to the Clinical Safety team across medical device clinical studies and post-market safety activities.
• Serve as the primary operational coordinator for assigned safety projects and committee activities, ensuring deliverables, timelines, and documentation requirements are successfully executed.
• Assist with management of independent safety review committees (Clinical Events Committees (CECs) and Data Safety Monitoring Boards (DSMBs)), including preparation of meeting materials, meeting participation, and appropriate documentation of meeting outcomes.
• Coordinate safety-related project tracking, timelines, documentation, meeting scheduling, and action item follow-up.
• Support the collection, review, and maintenance of safety documentation, including adverse event reports, product complaints, and safety tracking logs.
• Assist with case intake, data entry, quality checks, and organization of safety records in accordance with internal procedures and regulatory requirements.
• Prepare meeting materials, project status reports, metrics, and presentations for internal and client-facing discussions.
• Participate in client meetings and support preparation of client-facing safety updates, reports metrics, and presentations.
• Partner with Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, and project teams to ensure timely communication and resolution of safety-related activities.
• Support inspection and audit readiness activities through maintenance of accurate documentation and safety records.
• Assist with implementation and refinement of safety processes, workflows, and standard operating procedures.
• Participate in safety team meetings and contribute to process improvement initiatives designed to enhance operational efficiency and compliance.
• Maintain awareness of applicable FDA, EU MDR, ISO 14155, vigilance, and post-market surveillance requirements governing medical device safety activities.

Skills

Organizational skills

Communication skills

Attention to detail

Multitasking

Team collaboration

Time management

Education

Bachelor's degree (Nursing, Life Sciences, Health Sciences, Public Health, Biology, Biomedical Sciences, or related)

Tools

Microsoft Office

Job description

IQVIA is seeking a MedTech Safety Project Lead to provide operational, project coordination, and administrative support to the Clinical Safety team across clinical and post-market safety programs.

The role coordinates safety projects, committees (CECs, DSMBs), and documentation, ensuring timely deliverables, compliance with FDA/EU MDR/ISO standards, and collaboration across Clinical Operations, Regulatory Affairs, Quality, and Medical Affairs.