Post Market Surveillance (PMS) Analyst

Job description

The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Post Market Surveillance (PMS) Analyst to be located in Cincinnati, OH.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Post Market Surveillance Analyst will collaborate with a team of statisticians, engineers and analysts in support of post market surveillance processes.

• Executing post market product data analysis processes in support of Product Quality Safety Surveillance Data Review Board (PQSS DRB) Meetings.
• Responsible for providing post market surveillance data in support of regulatory health authority requests, root cause investigations, and new product development.
• Ensuring the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required.
• Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.
• Reviews and continuously executes the global post market surveillance process. Extracts monthly post market quality data and maintains compliant records.
• Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection.
• Evaluates Safety Signals through data analytics mainly, Adverse Event reporting, Non-Conformance Reports, Corrective Actions/Preventative Actions, Customer Feedback and FG Product testing data.
• The post market surveillance data set is large and includes reported product complaints, malfunctions, and adverse events, as well as capital equipment service records, clinical reviews, company-sponsored funded registries, post-market studies, and literature reviews. As required, responsible for summarizing trends, signals, and escalations.
• Ensures appropriate governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate.
• Executes filing of appropriate post-market, safety surveillance-related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures. Supports engineering and other ad-hoc data queries in support of PQSS DRB and other post market quality related requests.
• Completes projects/other duties as assigned. Provides support during external and internal audits of the post market surveillance processes.

Desired profile

Qualifications :

• A minimum of a Bachelor's degree is required.
• An Advanced degree (MBA or MS) and a concentration in a technical, scientific, engineering or related field is preferred.
• A minimum of 2 years of relevant business experience is required.
• Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment is required.
• An understanding of basic statistical analysis software packages (SAS, R, SPSS, SQL) is preferred.
• Six Sigma Green Belt, Black Belt, or Master Black Belt certification is preferred.
• Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred.
• A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required.
• Experience with analysis and signal detection in a large data set is preferred.
• Understanding of Risk Management is preferred.
• Prior experience in the medical device industry or an FDA regulated environment is preferred.
• Experience executing data management tasks and working with complaint investigations, root cause analysis, identification and implementation of CAPAs are preferred.
• Project management skills and the ability to maintain excellent electronic records is required.
• Intermediate to Advanced MS excel is required (Pivot tables, Vlookup, formulas).
• Proficiency in MS Word and MS PowerPoint is required.
• Experience with electronic Complaint Management System and technical documents is preferred.
• This position is located in Cincinnati, Ohio and may require up to 5% travel.

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Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.