Senior Specialist, Clinical Safety

Senior Specialist, Clinical Safety

$130,000-$140,000

Remote (USA)

Reporting to Clinical Safety leadership, the Senior Specialist, Clinical Safety will support the safety oversight of multiple ongoing clinical studies for innovative cardiovascular medical devices. This individual will independently manage a high volume of concurrent safety activities across several active studies, ensuring timely execution of safety reporting requirements while maintaining compliance with applicable regulatory standards, study protocols, and internal procedures. The role requires exceptional organizational skills, sound clinical judgment, and the ability to manage competing priorities in a fast-paced environment with minimal oversight.

Responsibilities

• Independently manage safety activities across multiple active clinical studies while balancing competing priorities and timelines.
• Assess and report adverse events (AEs), serious adverse events (SAEs), device complaints, and potential unanticipated adverse device effects (UADEs).
• Analyze safety data and identify potential trends, risks, or emerging safety signals.
• Monitor site reporting compliance and ensure adherence to protocol-defined timelines.
• Collaborate with investigative sites, clinical monitors, and cross-functional teams to resolve safety-related queries and obtain supporting documentation.
• Prepare clinical event narratives, aggregate safety summaries, and supporting documentation for internal and regulatory review.
• Support annual regulatory reports, safety submissions, and health authority responses.
• Develop safety presentations, dashboards, and reports for leadership and independent oversight committees.
• Provide subject matter expertise related to adverse event reporting, MedDRA coding, and clinical safety processes.
• Partner with Clinical Operations, Data Management, Regulatory Affairs, and Biostatistics to ensure data quality and reporting accuracy.
• Contribute to protocol development, safety management plans, case report forms, and other study-related documentation.
• Support clinical event adjudication and safety committee activities, including meeting preparation and follow-up.
• Mentor junior team members and contribute to process improvement initiatives that enhance operational efficiency and scalability.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related discipline required; advanced clinical degree preferred.
• 5+ years of experience in Clinical Safety, Pharmacovigilance, Clinical Affairs, or a related function within the medical device, biotechnology, or pharmaceutical industry.
• Strong knowledge of GCP, ICH guidelines, HIPAA, and regulations governing clinical research.
• Demonstrated experience supporting multiple concurrent clinical studies in a deadline-driven environment.
• Experience with adverse event reporting, safety databases, MedDRA coding, EDC systems, and regulatory submissions.
• Cardiovascular, interventional cardiology, structural heart, or implantable medical device experience preferred.
• Strong analytical, organizational, written, and verbal communication skills.
• Ability to work independently while collaborating effectively with cross-functional teams and external stakeholders.
• Travel up to 10%

If you're interested in this role, please apply now!