CLINICAL SAFETY ANALYST | REMOTE

The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients.

Activities performed under this team:

  • Assisting with ongoing continuous improvement projects spanning across departmental needs

  • Providing support for training and automation efforts

  • Identify regional label variances and build tool to capture info for priority products and main competitors

  • Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed.

  • Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products.

  • Participate in root-cause investigations into device failures and human factors-related use errors.

Qualifications Desired Skills:

  • Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation

  • Knowledge of Research & Development and an understanding of regulatory guidelines / requirements related to R & D Medical Devices / Combination Products (e.g., ICH, GCP, CFR, EU-MDR, safety reporting)

  • Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, other database tools)

  • Ability to effectively interact with and influence others without direct reporting relationships

  • Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs


Core Essential Skills:

  • Ability to Meet Challenging Milestones with results orientation – Skilled

  • Strategic Decision Making and Negotiation – Skilled

  • Facilitating Change and managing conflicts – Skilled

  • Ability to Problem Solve Independently & with Others – Highly Skilled

  • Business Organization & Industry Awareness – Highly Skilled

  • Cross Functional Relationships and communication skills – Highly Skilled

  • Execution / Results / Process Improvement – Highly Skilled

Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) *CO candidates may not be considered


APPLY NOW

Related Posts

See All

Our team is looking for a Data Analysis Intern to join them in the upcoming weeks. This position is great for an aspiring data analysis professional looking to work on business-critical projects and g

As an Associate Gameplay Engineering Intern, you will be responsible for helping to create technology for an exciting new project being developed by Archetype Entertainment. You’ll work with the lates

We are creating a new science fiction universe for our first multiplatform roleplaying video game and are looking for Interns to join us virtually for Fall 2022. Over the course of 13 weeks, a select