Staff Medical Safety Specialist - Remote

Overview

The Staff Medical Safety Specialist at Dexcom plays a critical role in ensuring the safety of participants in clinical research by overseeing safety processes across global clinical trials.

In Short

• Review adverse events for consistency, clarity, and completeness.
• Process adverse events and serious adverse events according to protocol-specific requirements.
• Triage safety events to appropriate medical monitors or team members.
• Collaborate with study medical monitors, managers, and data management teams.
• Develop and disseminate safety reports and listings.
• Advise on safety monitoring rules and adverse event reporting workflows.
• Ensure timely and accurate reporting to regulatory authorities.
• Foster strong cross-functional relationships for enhanced clinical safety oversight.
• Requires knowledge of EU MDR, ICH Guidelines, and FDA regulations.
• Experience in biotech or medical safety roles is essential.

Requirements

• Bachelor’s degree in a healthcare profession or equivalent clinical experience.
• At least 2 years of experience in a biotech or medical safety role.
• Proficiency with coding dictionaries such as CTCAE, WHODrug, and MedDRA preferred.
• Familiarity with continuous glucose monitoring devices is a plus.
• Strong understanding of global safety reporting requirements.

Benefits

• Comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs.
• Exciting and innovative organization committed to employees and communities.
• Travel required: 5-15%.