Boston Scientific Senior Medical Safety Specialist 

United States, Minnesota 

928353485

About the 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.

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 3 years of experience in Interventional Radiology or Interventional Oncology

Preferred qualifications:

• Experience in clinical/scientific research, preferably with medical devices and clinical trials
• 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

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.