Staff Clinical Safety Specialist

🔥 16 minutes ago

🏄 California – Remote

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💵 $95.7k - $175.5k / year

⏰ Full Time

🔴 Lead

🦅 H1B Visa Sponsor

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Logo of Stryker

Stryker

10,000+ employees

Founded 1941

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Stryker is a global leader in medical technology, providing innovative products and services across the healthcare sector. With a presence in countries across the Americas, Asia Pacific, Europe, and the Middle East & Africa, Stryker offers a wide range of medical technologies, including orthopedic implants, surgical equipment, and advanced hospital devices. The company is committed to improving patient outcomes and healthcare efficiency. Stryker continues to expand its global reach, offering localized solutions to meet diverse healthcare needs worldwide.

📋 Description

• Lead clinical safety oversight activities across assigned studies • Review and evaluate adverse events, serious adverse events, protocol-defined endpoints, and other safety signals • Author and review clinical event narratives • Partner with Clinical Operations, Medical Affairs, Data Management, Biostatistics, Regulatory Affairs, and Quality teams • Coordinate with clinical sites, contract research organizations, field monitors, medical monitors, and adjudication committees • Perform and oversee clinical safety event coding activities • Present safety findings, event summaries, adjudication outcomes, and emerging trends during safety review meetings • Drive continuous improvement initiatives that enhance safety processes, inspection readiness, and compliance

🎯 Requirements

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related discipline • Minimum 4 years of experience in clinical research, clinical safety, pharmacovigilance, medical device vigilance, or a related field • Working knowledge of Good Clinical Practice (GCP), U.S. Food and Drug Administration (FDA) regulations • Experience assessing and documenting adverse events, serious adverse events, and other clinical safety events within regulated clinical studies.

🏖️ Benefits

• Health insurance • Retirement plans • Professional development opportunities

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