HireDiversity

Somerville, NJ, US

POST-MARKET SURVEILLANCE ANALYST (1 of 2)-6435130104

Description

Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Post-Market Surveillance Analyst (1 of 2), to be located in Somerville, New Jersey OR Cincinnati, Ohio.

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 PMS Analyst is responsible for the signal analysis and detection of product safety, performance and quality indicators in reactive/proactive data sets. This individual works with internal and external customers and builds relationships with organizational partners that generate post-market data. Works independently with minimal supervision. Executes tasks, manages projects, and implements critical procedural elements. Tasks assigned by Manager or Director of PMS.

The PMS Analyst performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection. Evaluates Safety Signals through data analytics. Interfaces with electronic quality systems databases (CAPA, PLM, CHATS, COGNOS) to collate PMS data. Performs signal detection and assessment of PMS data, mainly Adverse Event reporting, NCR, CAPA, PQI, Customer Feedback and FG Product testing data utilizing the following tools/techniques: Interval Frequency Analysis, Aggregate Analysis, Proportionality Analysis, and Stratification Analysis.

The PMS Analyst executes the PMS process with a primary focus on product performance, safety and efficacy. Active member of PMS data reviews for both reactive and proactive data sources. Interfaces with internal partners, mainly R&D, Operations, Medical Affairs, and Marketing. Interfaces with external partners including sales representatives. Interfaces with electronic systems (e.g. CAPA, CHATS, TRIM, ADAPTIV). Utilizes statistical tools to provide technical groups and sales/marketing groups with the appropriate information on field product quality. Develops and maintains PMS tracking and trending reports as assigned by manager. Supports Managers or Director on various projects. Works independently with minimal supervision.

Qualifications


A Bachelor's degree in a Scientific, Technical, Engineering, or related field and a minimum of 1 year of relevant experience is required. Knowledge of statistical applications (e.g. Minitab, SAS, etc) is a plus. Knowledge of MS Office (Excel, Word, etc) is required. Technical experience (e.g. systems, software programs, analytical research, etc) is required. Medical Devices/diagnostics and/or other regulated industry experience is required. Good written and oral communications skills and good computer skills are required.

Up to approximately 10% international and domestic travel may be required. This position can be located in Somerville, New Jersey OR Cincinnati, Ohio.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Somerville
Other Locations:North America-United States-Ohio-Cincinnati
Organization: Ethicon Inc. (6045)