Senior Clinical Safety Specialist

Additional Location(s): US-MA-Marlborough; US-MN-Minnetonka

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 Senior Clinical Safety 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. 
 

This is a hybrid position (in office minimum three days per week) with the flexibility to be in Maple Grove, MN or Marlborough, MA or Valencia, CA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

 

Your responsibilities will include: 
⦁    Manage adverse event processing including report review, safety query management, and expedited reporting 

⦁    Assess type/level of processing to be done for adverse events 

⦁    Author study specific safety documents and plans (eg: safety plan, CEC/IMR Charter, etc.) 
⦁    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 
 

Required qualifications: 
⦁    Minimum bachelor’s degree or equivalent experience 
⦁    Minimum 5 years clinical trial experience within role of safety 
⦁    Proven or prior experience with clinical trial safety 

 

Preferred qualifications: 
⦁    Therapeutic knowledge in Urology 
⦁    Knowledge of GCP
⦁    Experience with processing and assessing safety events and medical narrative writing 
⦁    Clinical database and systems
 

 

 

 

 

Requisition ID: 

Minimum Salary: $ 80100 

Maximum Salary: $ 152200 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

 

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements.

 

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a r