Staff Medical Safety Specialist
Staff Medical Safety Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later having pioneered an industry. And were just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized actionable insights aimed at solving important health challenges. To continue what weve started: Improving human health.
We are driven by thousands of ambitious passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening serving with integrity thinking big and being dependable. Weve already changed millions of lives and were ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve come a long way from our small company days our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
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 youll play a pivotal role in safeguarding participants by overseeing safety processes across global clinical trials. Our team thrives on cross-functional collaboration continuous learning and making a real impact in the lives of patients. If youre looking for a role where your clinical expertise meets purpose-driven innovation this is the place for you.
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.
What makes you successful:
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.
What youll get:
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.
Travel Required:
5-15%
Experience and Education Requirements:
Typically requires a Bachelors degreein a technical discipline and a minimumof 8-12 years related experience orMasters degree and 5-7 years
equivalent industry experience or a PhDand 2-4 years of experience.
#LI-Hybrid
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Required Experience:
Staff IC
Employment Type
Full-Time
