Program Safety Specialist II

Additional Location(s): N/A

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 the role: The Safety Program Specialist II position manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring and ensuring execution of project specific safety plans as well as overseeing event and complaint processing in accordance with study specific operational plans.

Your responsibilities will include

• Author study specific safety documents and plans (eg: safety plan, complaint plan, CEC/IMR Charter, etc.).
• Assess type/level of processing to be done for adverse events.
• Manage adverse event processing including report review, safety query management and expedited reporting.
• Performs medical review and assessment of adverse events in clinical trials.
• Acting member of clinical core team.
• Conduct Clinical Trial Safety Review meetings.
• Ensure adjudication and reconciliation of safety events are completed prior to data snapshots (if applicable).
• Provide safety-related input to other study documents/processes as requested (eg: 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.
  

Required 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
• Working knowledge of ARGUS and EDC systems
• Knowledge of GCP
• Knowledge of medical terminology

Preferred qualifications:

• Experience with processing and assessing safety events and medical narrative writing
• Clinical trial experience within role of Safety
• Strong analytical and problem-solving skills
• Solid understanding of functional specialty
• Independently determines and develops approaches to solutions
• Excellent organization skills
• Therapeutic knowledge in Urology a plus
• Good written and oral communication skills with high attention to detail
  

Requisition ID: 560192

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 drug-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.