Safety Review Specialist in Cary, IL at Stryker Corporation

掲載日付: 10/13/2019

求人のスナップショット

仕事内容

At Stryker's Sage division, we develop products used to prevent hospital-acquired conditions such as ventilator-associated conditions, skin injury due to incontinence, pressure injuries, surgical site infections and healthcare worker injury across the continuum of care. From the acute care setting to the skilled nursing and long-term care setting, as well as continued care at home, we create products that make care giving easier and provide clinical outcomes. Our success is supported by a unique culture that is summed up in the phrase, “keep it personal”. It’s our way of reinforcing a focus and commitment to our employees and customers through integrity, honesty and passion. We are searching for a Safety Review Specialist to support domestic and international drug, medical device, and cosmetic products.  This role will ensure timely and accurate review, processing, and reporting of adverse events. 

Who we want

  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

  • Facilitate product complaint process by providing performing safety review to determine seriousness and event resolution
  • Prepare and submit adverse event reports to regulatory agencies
  • Engage external customers in verbal or written communication regarding complaints and/or inquiries
  • Monitor scientific literature reviews; submit adverse event reports as necessary
  • Prepare Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update reports (PSUR)
  • Engage internal customers in written and verbal communication concerning internal procedures and regulatory requirements for products and labeling
  • Facilitate training on product complaint and adverse event reporting requirements
  • Support Post Market Surveillance for EU Medical Devices
  • Prepare and monitor customer letters
  • Monitor and present on monthly quality metrics related to adverse event reporting
  • Participate in quality audits, acting as a subject matter expert for customer complaints and adverse event reporting

What you need

  • Bachelors degree in Nursing, Biomedical Engineering, Science or related field
  • 5+ years experience working in a clinical setting
  • Excellent writing and analytical skills
  • Strong product knowledge and clinical impact
  • Must be highly customer-service oriented
  • Trackwise experience preferred

You may also have

  • Masters in Nursing, Biomedical Engineering, Science or related
  • Knowledge in pharmaceutical or medical device regulations, regulatory affairs and compliance

Work From Home: Not available

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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