Senior Medical Safety Specialist

Additional Location(s): US-MN-Arden Hills; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Marlborough; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-Plymouth

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 this role:
This role manages surveillance processes across a wide range of Peripheral Interventions products and disease states such as Peripheral Artery Disease, Carotid Artery Disease, Venous Disease, Pulmonary Embolism, Malignant & Benign Tumors, Gastrointestinal Disease, Abscesses and more. 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 alongside Medical Safety colleagues and under supervision of the Medical Director/ Medical Safety Manager.

 

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

 

Your responsibilities will include:
⦁    This role will provide medical support to the Medical Devices within Peripheral Interventions business (PI).
⦁    Applies knowledge and experience of clinical medicine to a wide range of PI products in one or more therapeutic areas.
⦁    Receives and analyzes data from multiple sources (clinical trials, complaints, Medical Device Reports, etc.), identifies potential safety issues, and participates in trend analysis.Provides accurate, succinct summaries at team and cross functional meetings. 
⦁    Performs medical review and assessment for individual case safety reports, aggregate reports, literature, risk management and other required documents.
⦁    Represents Medical Safety at multi-functional team meetings such as complaint trend meetings.
⦁    Works closely with Analyst team, Medical Directors and Manager to produce clear and concise communication of complex data.  
⦁    Escalates potential patient safety issue for decision-making and/or potential action by senior leadership.
⦁    Seeks opportunities for continuous quality improvement.
⦁    Applies working knowledge of medical device regulations and standards (globally).

 

Required qualifications:
⦁    Bachelor's level degree or equivalent in healthcare related field. Examples of health-related field professionals include registered nurse, physician’s assistant, and nurse practitioners.
⦁    Minimum of 5 years of direct patient care experience preferably in a hospital, interventional setting or outpatient surgical center. 
⦁    Minimum of 5 years of experience in clinical/scientific research, preferably with medical devices and clinical trials

 

Preferred qualifications:
⦁    Post Market Surveillance experience in medical device industry preferred
⦁    Oncology or Vascular product experience preferred
⦁    Ability to think analytically and process scientific and medical data, with the ability to multi-task and problem solve
⦁    Must possess the ability to work and make independent decisions, understand complex medical information, and be able to take the initiative to lead projects and assignments
 

Requisition ID: 593171

 

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

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 customer