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Product Safety Specialist - Drugs

Company: Job Juncture
Location: Covington
Posted on: February 28, 2020

Job Description:

The Product Monitoring Specialist will be responsible for monitoring the safety, quality and efficacy of drug and medical device products.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

  • Capture, review, enter into tracking system, and analyze product complaints and serious adverse events (SAE)
  • Ensure that adverse event reports are received, tracked, evaluated, processed and reported
  • Initiate and coordinate investigations for complaints and MDRs
  • Participate in Health Hazard Evaluation (HHE) process
  • Coordinate product safety communications to other departments including regulatory affairs, R&D, marketing and sales.
    EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
    • BS degree in a life science
    • 2+ years drug safety / product monitoring experience
    • Knowledge of FDA and EU safety reporting requirements for both pharmaceuticals and medical devices
    • Experience with Health Hazard Evaluations preferred
    • Experience with pharmacovigilance documents such as SOPs, guidelines, safety plans
    • Excellent written and oral communication skills

Keywords: Job Juncture, Middletown , Product Safety Specialist - Drugs, Other , Covington, Ohio

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