Senior Safety Program Specialist

Boston Scientific - Minnetonka, MN

Full-time - Mid Level

Minnetonka, MN

Miscellaneous Manufacturing

About the position

The Senior Safety Program Specialist at Boston Scientific is responsible for managing adverse event reporting and safety deliverables for investigational and marketed products within the Urology division. This role involves authoring project-specific safety plans, overseeing event processing, and ensuring compliance with operational plans, all while contributing to the clinical core team and conducting safety review meetings.

Responsibilities

• Author study specific safety documents and plans (e.g., safety plan, CEC/IMR Charter)
• Assess type/level of processing to be done for adverse events
• Manage adverse event processing including report review, safety query management, and expedited reporting
• Acting member of clinical core team
• Conduct Clinical Trial Safety Review meetings
• Ensure adjudication and reconciliation of safety events are completed prior to data snapshots
• Provide safety-related input to other study documents/processes as requested (e.g., protocol, CRF design)
• Manage functional deliverables to ensure study milestones are not delayed
• Management of additional projects, deliverables, and timelines to support additional activities within the clinical department
• May perform medical review and assessment of adverse events in clinical trials

Requirements

• 5 years clinical trial experience within role of Safety
• Therapeutic knowledge in Urology
• Strong analytical and problem-solving skills
• Knowledge of GCP
• Knowledge of medical terminology
• Excellent written and oral communication skills and high attention to detail

Nice-to-haves

• Licensed healthcare professional or certified personnel with clinical knowledge and relevant direct patient care experience (e.g., CMA, RMA, CST, RN, MD, PA, NP)
• Experience with processing and assessing safety events and medical narrative writing
• Solid understanding of functional specialty
• Clinical database and systems experience
• Independently determines and develops approaches to solutions
• Excellent organization skills

Benefits

• Competitive salary
• Access to the latest tools and training
• Opportunities for career advancement
• Supportive work environment