Safety Program Specialist II

Additional Locations:  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 Prog position manages adverse event reporting and safety deliverables for investigational and marketed products. The position is responsible for authoring and ensuring execution of the project specific safety plan 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.
• 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.).

Required Skills:

• Effective verbal and written communication skills.
• Strong analytical kills for identifying and addressing safety-related issues.
• Exceptional organizational and time management skills to prioritize tasks and meet deadlines.

Required qualifications:

• Bachelor’s degree (or equivalent) nursing, science or related field.
• Minimum of 3 years in clinical/scientific research, medical device, or clinical trials experience.

Preferred qualifications:

• Knowledge of device therapies in Electrophysiology, Watchman and Rhythm Management.
• Experience in processing and assessing safety events in clinical trials.
• Familiarity with Good Clinical Practice (GCP) guidelines.
• Knowledge of applicable safety regulations, including ISO 14155 and 21 CFR 812.

#CRTA #CRGH

Requisition ID: 622927

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!