Job Description Summary

Job Description

The Post Market Surveillance (PMS) Specialist II will collect, analyze, trend and report on safety data to proactively identify potential adverse safety risks or performance trends.  Provides clinical and safety data assessment of post-marketing events.  The incumbent will collaborate with cross-functional team members to ensure compliance to the applicable regulations, standards and company policies/procedures to help improve the lives of the people we serve by ensuring high standards of quality and safety of the medical devices being produced.  Key Performance Indicator metrics are measured and analyzed for continuous improvement opportunities with subsequent action taken as appropriate.  This position plays an integral role in maintaining compliance with global regulations.

This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 30, 2022.

Essential Duties and Position Responsibilities 

• Work with PMS team to meet the requirements in generating PMS, Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents such as Risk Management Files (RMF) spanning 3 facilities (Irvine, CA; Vernon Hills, IL; and Warwick, RI). 
• Assist PMS/PSUR planning and reporting.
• Assist complaint investigators as necessary.
• Assist with Risk Management File Maintenance.
• Position responsible for some regulatory reporting.
• Extract and generate PMS and operational performance data necessary for generating applicable reports.
• Analyze and interpret clinical and PMS data.
• Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity.
• Identify and evaluate new failure modes when encountered.
• Maintain procedures as necessary.
• Support responding to requests for additional information from competent authorities, registries and notified body.
• Support internal and external audits.
• Develop and maintain knowledge of support systems including MasterControl, JDE and TrackWise.
• Complete training by established due dates.
• Identify and escalate quality and personnel issues as necessary.
• Performs other related duties and responsibilities as assigned.

Skills and Experience

• Bachelors of Science degree in a technical discipline required.
• Minimum 3 years’ experience in the Medical Device, and/or other regulated industry (Pharma, IVD).
• Sound working knowledge of regulations and industry standards consistent with requirements for a manufacturer of globally distributed medical devices and pharmaceutical products.
• Strong computer skills and previous application of Microsoft Excel, Word, PowerPoint, Project, Visio, database management, statistical analysis and reporting packages.
• Ability to acquire, query and analyze data with focus on detail.
• Analytical skill and focus on detail.
• Demonstrates strong attention to detail, able to identify missing information, and evaluate accuracy of presented information.
• Demonstrates accuracy and thoroughness, applies feedback to improve performance, and monitors own work to ensure quality.
• Good written and verbal communication, problem solving and applied thinking skills.
• Team player with ability to successfully interact with representatives from a variety of disciplines within and external to BDI Surgery and Becton Dickinson.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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