Post Market Surveillance Specialist Job Listing at Kelly Services in Cary, IL (Job ID US3580005_BH9882867)

Description

Post Market Surveillance Specialist Pay: $30 - $32 per hour 
Shift: 1st 
  Detailed Description:

• Product Complaint Process: Facilitate the process by performing safety reviews to assess seriousness and resolution of events.
• Documentation: Document and maintain records of complaint investigations.
• Regulatory Reporting: Prepare and submit expedited drug and medical device reports to US and International regulatory agencies within the required timeframe.
• Adverse Drug Experience Reports: Prepare Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update reports (PSUR) for drug products.
• Customer Engagement: Communicate with external customers regarding complaints/inquiries and review/approve customer quality complaint investigations.
• Internal Communication: Communicate internally regarding procedures and regulatory requirements related to complaint handling systems and regulatory reporting.
• Training: Facilitate training on product complaint and adverse event reporting requirements.
• Post Market Surveillance: Support surveillance for EU Medical Devices.
• Quality Audits: Participate in audits as a subject matter expert for customer complaints and adverse event reporting.

  Education & Special Trainings:

• Required: Bachelor's degree in Nursing, Biomedical Engineering, Science, or related field; 5+ years experience in a clinical setting.
• Preferred: Strong product knowledge; Trackwise experience.

  Qualifications & Experience:

• Required: Clinically skilled, licensed health care professional; highly customer-service oriented; excellent oral/written communication skills; complaint handling experience; attention to detail; eagerness to assist customers.
• Preferred: Knowledge of FDA/International guidelines for drug/device safety reporting requirements.
• Must be local to Cary, IL or able to commute to be onsite if needed.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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