Boston Scientific Senior Safety Program Specialist 

United States, Minnesota, Minnetonka 

232535570

About the role:

The Senior Safety Program Specialist manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring and ensuring execution of project-specific safety plans as well as overseeing event and complaint processing in accordance with study-specific operational plans.

Your responsibilities will include:

• Author study specific safety documents and plans (eg: safety plan, CEC/IMR Charter, etc.)
• 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 (eg: protocol, CRF design, etc.)
• 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

Required qualifications:

• 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

Preferred qualifications:

• 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

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.