Medical Safety Manager II

Additional Location(s): US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; 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 is responsible for the implementation of practices, policies, and processes for the Rhythm Management Medical Safety team to ensure medical expertise, objective oversight and safety vigilance throughout the total product lifecycle. The Medical Safety Manager II manages and facilitates the completion of accurate, timely, and consistent medical assessment of adverse events and potential adverse events.The Medical Safety Manager II provides leadership to safety professionals (non-MDs) to provide high level medical/ therapeutic guidance to internal and external customers. This role may also include individual contributor responsibilities related to Medical Safety oversight of sustaining RM therapies. 
 
Your responsibilities will include:

• Ensure the processes and training curriculum are current to support medical safety oversight and input into Clinical (BSC sponsored clinical trials) and Quality (product complaint handling).
• Support the Quality organization and assists in the creation, implementation, and harmonization of standard policies and procedures.
• Recognize and directs organizational development needs and opportunities for continuous improvement within Medical Safety.
• Drive comprehensive, integrated analysis of a potential safety issue.
• Ensure early medical review of clinical trial Serious Adverse Events to identify unanticipated adverse device effects.
• Represent Medical Safety in cross functional working groups on matters affecting patient safety in the functional areas such as clinical studies, post market surveillance and risk management.

 
Required qualifications:

• Minimum of bachelor’s degree in healthcare/life science related field. 
• Active licensure as an RN, DNP or PA
• Minimum of 8 years of direct patient care experience, electrophysiology or cardiology 
• Minimum of 2 years of related work experience in Medical Safety, clinical research, and/or clinical quality.
• Strong leadership competencies – particularly communication, collaboration, planning, innovation, and strategic thinking.
• Excellent communication and people skills.

 
Preferred qualifications:

• Demonstrated proficiency in staff leadership and development.
• Experience in operational safety within clinical studies.
   

Requisition ID: 581632

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal 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 customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.