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Safety Program Specialist I Job

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Date: Nov 16, 2020

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Arden Hills; US-MN-Minnetonka

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About the role:

The Safety Program Specialist position manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology and Pelvic Health division. This entry level position is responsible for supporting, co- authoring, and ensuring execution of project specific safety plans, as well as overseeing event and complaint processing in accordance with study specific operational plans, in collaboration with other safety team members and the study team.

 

Your responsibilities will include

  • Collaboration and co-author (with other safety trial managers) study specific safety documents and plans (e.g., safety plan, complaint plan, CEC/IMR Charter, etc.).
  • Collaborate, facilitate, and review with team members the type and level of processing to be done for adverse events.
  • Support and co-manage adverse event processing including report reviews, safety queries, management and expedited reporting.
  • Acting member of clinical core team.
  • Support and co-conduct Clinical Trial Safety Review meetings.
  • Support the event adjudication and reconciliation of safety events by collecting required documentation from clinical sites, and ensuring data entry is completed prior to data snapshots (if applicable).
  • Provide safety-related input to other study documents and processes as requested (e.g.,: protocol, CRF design, etc.).
  • Manage functional deliverables to ensure study milestones are not delayed.
  • Management of additional projects, deliverables, timelines to support additional activities within the clinical department

 

What we’re looking for in your:

Minimum Qualifications

  • Bachelor’s level degree required in Biological Sciences/health related fields   
  • 1+ years of clinical/safety experience
  • Strong analytical and problem-solving skills
  • Knowledge of GCP (good clinical practice)
  • Knowledge of medical terminology
  • Good written and oral communication skills with high attention to detail

 Preferred Qualifications

  • Working knowledge of ARGUS and EDC systems
  • Experience with processing and assessing safety events and medical narrative writing
  • Clinical trial experience within role of Safety
  • Solid understanding of functional specialty
  • Independently determines and develops approaches to solutions
  • Excellent organization skills
  • Therapeutic knowledge in Urology and Pelvic Health a plus

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 471328

 


Nearest Major Market: Boston

Job Segment: Medical, Medical Technology, Urology, Data Entry, Healthcare, Administrative, Entry Level