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Staff Medical Safety Specialist
4 weeks ago
Overview
Dexcom Manila, National Capital Region, Philippines
Join to apply for the Staff Medical Safety Specialist role at Dexcom .
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). We are driven by thousands of ambitious, passionate people worldwide who work to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. Our future is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We are focused on improving human health through personalized, actionable insights and biosensing-technology experiences.
Meet the Team: Join a passionate and collaborative Clinical Safety team dedicated to ensuring the highest standards of patient safety in clinical research. As a Staff Clinical Safety Monitor, you’ll oversee safety processes across global clinical trials and collaborate cross-functionally to safeguard participants and impact patient lives.
Where You Come In- You review adverse events (AEs) for consistency, clarity, and completeness, identifying trends and anomalies through continuous quality review.
- You process AEs and Serious Adverse Events (SAEs) per protocol-specific requirements, including initial evaluation, data completeness checks, and coordination with sites for clarification or additional documentation.
- You triage safety events to the appropriate medical monitor or team member and follow up on AE/SAE outcomes.
- You collaborate with study medical monitors, study managers, clinical monitors, and data management to ensure seamless safety review activities.
- You partner with data management and biostatistics to develop and disseminate safety reports and listings.
- You contribute to protocol, safety plan, and case report form development by advising on safety monitoring rules and AE reporting workflows.
- You ensure timely and accurate reporting of adverse events to regulatory authorities, ethics committees, and other relevant bodies.
- You foster strong cross-functional relationships to maintain and enhance Clinical Safety oversight across programs.
- You have a deep understanding of EU MDR, ICH Guidelines, GCP, and FDA regulations.
- You bring knowledge of global safety reporting requirements, particularly for medical devices.
- You apply medical concepts and terminology effectively across clinical and operational settings.
- You hold a degree in a healthcare profession (e.g., BSN, PA, APRN, NP, PharmD, or DO/MD) with equivalent clinical experience.
- You have at least 2 years of experience in a biotech or medical safety role.
- Your proficiency with coding dictionaries such as CTCAE, WHODrug, and MedDRA is preferred.
- Your familiarity with continuous glucose monitoring devices and diabetes management is a plus.
- A front row seat to life-changing CGM technology. Learn about our brave #dexcomwarriors community.
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
- 5-15%
- Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or Master’s degree and 5-7 years; or equivalent industry experience or a PhD and 2-4 years of experience.
