American Free Zone, San Franci Safety Program Specialist II AFZ

Job description

Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the Role The Safety Program Specialist II is responsible for supporting the oversight and management of clinical trial safety activities for investigational and marketed medical devices within the Rhythm Management division. This role includes adverse event and device deficiency assessment, safety reporting, development and execution of study-specific safety plans, and collaboration with cross-functional teams to ensure timely, accurate, and compliant safety deliverables throughout the clinical study lifecycle. Your Responsibilities Will Include: Develop, maintain, and execute study-specific safety plans and supporting documentation (e.g., Safety Plans, Complaint Plans, CEC/IMR Charters). Evaluate adverse events and device deficiencies to determine appropriate assessment, processing, and reporting requirements. Coordinate and oversee safety event processing, including data review, query resolution, and reporting timelines. Support clinical and medical assessment of safety events in collaboration with designated medical reviewers. Represent Clinical Trial Safety on cross-functional clinical study teams. Coordinate and facilitate Clinical Trial Safety Review meetings, including follow-up on action items. Coordinate safety event adjudication and reconciliation activities to support study milestones and data quality. Provide safety-related input into clinical study documents and processes, including protocol development and case report form (CRF) design. Identify, communicate, and escalate potential safety concerns, data quality issues, and process gaps to appropriate stakeholders in a timely manner. Ensure timely delivery of functional safety outputs to support clinical study milestones. Support departmental initiatives, process improvements, and other safety-related deliverables as assigned. Required Skills Strong analytical and critical-thinking skills with the ability to evaluate complex clinical safety information. Effective written and verbal communication skills, including the ability to collaborate with cross-functional stakeholders. Strong organizational and prioritization skills with the ability to manage multiple studies, competing priorities, and deadlines. Ability to work independently, exercise sound judgment, and escalate safety-related issues appropriately. Strong attention to detail and commitment to data quality, regulatory compliance, and timely execution. Required Qualifications Bachelor’s degree in nursing, life sciences, healthcare, or a related field, or an equivalent combination of education and relevant experience. Minimum of two years of relevant experience in clinical research, medical devices, clinical trial operations, or clinical safety. Preferred Qualifications Experience with clinical trial safety management, including adverse event and device deficiency assessment, processing, and reporting. Knowledge of medical device clinical research regulations and standards, including ISO 14155, 21 CFR Part 812, and applicable Good Clinical Practice (GCP) requirements. Experience developing or executing clinical study safety plans and supporting safety-related study deliverables. Familiarity with clinical data management systems, safety databases, and electronic data capture (EDC) systems. Knowledge of medical device therapies, particularly Cardiac Rhythm Management, Electrophysiology, or Watchman. Requisition ID: 636482 Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn . 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