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Senior Medical Safety Specialist Job

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Date: Jan 7, 2019

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 this role:

Role manages surveillance processes across a wide range of business unit products and disease states. Reviews surveillance data to ensure patient safety signal trending synthesis throughout the lifecycle of the business unit products. Responsible for medical review of adverse event data. Completes accurate, timely, and consistent medical assessment of adverse events and potential adverse events in order to provide medical expertise, objective oversight and ensures safety vigilance throughout the total product lifecycle. Major interfaces include: Clinical, Regulatory, Quality, Post Market Surveillance, Complaint Management Center and functional management. Performs work under limited supervision of the Medical Director or with consultation from Medical Safety peers and Safety Trial Managers.

 

Your responsibilities will include:

  • Applies knowledge and experience of clinical medicine to a wide range of medical devices in one or more therapeutic areas including but not limited to Women’s Health (gynecological surgery, pelvic organ prolapse, urinary incontinence), Men’s Health (erectile restoration, urinary incontinence), Prostate Health (benign prostatic hypertrophy), and Stone (urinary tract stones).
  • Receives, analyzes pre-scheduled and ad-hoc data from multiple sources (clinical trials, complaints, Medical Device Reports), identifies safety issues and participates in trend analysis for input into internal and external Medical Safety reports.
  • Represents Medical Safety at multi-functional team safety trend meetings.
  • Works closely with Medical Director, to produce clear and concise communication of complex data.
  • Escalates potential patient safety issue for decision-making and/or potential action by senior leadership
  • Provides medical safety support to maintain risk documentation for existing products and helps develop risk documents for new products in development.
  • Seeks opportunities for continuous quality improvement.
  • Applies medical device regulations and standards appropriately (globally).
  • Supports team and participates in internal and external audits
  • May be required to perform cross functional roles with Safety Trial Operations, such as writing safety narratives, processing product complaints, reviewing study protocols/case report forms and conducting clinical trial safety review meetings
  • Domestic business travel for scientific meetings, audits or business team meetings (up to 4 times per year).
  • Location: Minnetonka, MN (Arden Hills, MN in 2020) or Marlborough, MA

 

What we’re looking for in you:

Minimum qualifications

  • Bachelor's level degree or equivalent in healthcare/life science related field
  • 5 + years of direct patient care experience or experience in healthcare setting required. Examples of health-related field professionals include but are not limited to registered nurse, physician’s assistant, and nurse practitioners

Preferred qualifications

  • 5+ years of experience in clinical/scientific research, preferably with medical devices/pharmaceutical clinical trials
  • Familiarity with or experience in urology disease states
  • Post Market Surveillance experience preferred
  • Ability to manage complex projects
  • Excellent oral, written and computer skills required

 

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.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 441542

 


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