[Remote] Sr. Clinical Safety Specialist (Remote)

Note: The job is a remote job and is open to candidates in USA. Stryker Inari is seeking a Sr. Clinical Safety Specialist to ensure accurate, timely, and consistent safety assessments of adverse events across sponsored clinical studies and registries. This role focuses on consistent evaluation, documentation, and reporting of adverse events in alignment with global requirements while collaborating across study teams and external partners.ResponsibilitiesReview adverse events, serious adverse events, and endpoint-related events across clinical studies to ensure accurate assessment and documentationPrepare clinical safety narratives using source documents and study data, completing deliverables within defined timelines and quality standardsCollaborate with clinical sites and monitors to request, collect, and verify source documentation required for adjudicationApply MedDRA coding to adverse events to ensure standardized classification and consistency across studiesCoordinate with study teams, medical monitors, and adjudication committees to support protocol-aligned safety reviewsContribute to safety management plans for assigned protocols and support safety review meetings with documented findingsMonitor safety data quality by identifying discrepancies and implementing corrective actions to maintain completeness and accuracyMaintain compliance with Good Clinical Practice and regulatory requirements through adherence to standard operating procedures and audit readinessSkillsBachelor's degree2+ years of clinical research experienceExperience applying Good Clinical Practice standards in clinical trialsProficient with electronic databases used for clinical trials such as, Zelta, etcBachelor's degree in life science or related field2-4 years of experience in medical device clinical trialsExperience with adverse event review, safety reporting, or pharmacovigilance processesKnowledge of MedDRA coding standardsPossesses exceptional attention to detail and strong analytical skills to accurately review CRFs, source documents, and evaluate safety data for quality and complianceBrings medical knowledge and preferably experience in clinical trials or medical devices to support informed decision-making and data integrityBenefitsMedical and prescription drug insuranceDental insuranceVision insuranceCritical illness insuranceAccident insuranceHospital indemnity insurancePersonalized healthcare supportWellbeing programTobacco cessation programHealth Savings Account (HSA)Flexible Spending Accounts (FSAs)401(k) planEmployee Stock Purchase Plan (ESPP)Basic life and AD&D insuranceShort-term disability insuranceCompany OverviewStryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. It was founded in 1941, and is headquartered in Cestas, Aquitaine, FRA, with a workforce of 10001+ employees. Its website is http://www.stryker.com/en-us/index.html.