Safety Review Specialist

Stryker - Cary, IL3.9

Full-timeEstimated: $63,000 - $87,000 a year
EducationSkillsBenefits
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.