Lead Principal Medical Safety Analyst (Vendor Management)

AbbVieNorth Chicago, IL
94d$127,822 - $178,500Remote

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. The position involves supporting the case processing organization to achieve its mission of improving patient lives globally through consistent and accurate delivery of high quality, relevant, and timely adverse event management by providing effective oversight of external providers of Pharmacovigilance services for AbbVie. The role includes conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (clinical and post marketing) is performed in a compliant and timely manner to comply with global regulations and to ensure company standards for quality, compliance and productivity are met.

Requirements

  • Must have a Bachelor's in Pharmacy, Nursing or related Life Science field.
  • 4 years of experience in conducting drug safety Pharmacovigilance in a pharmaceutical or related industry.
  • Experience leading project work and teams in Pharmacovigilance.
  • Experience managing case processing processes, procedures, and conventions.
  • Knowledge of industry regulations (ICH, FDA, EMEA, MHRA).

Responsibilities

  • Support case processing organization to improve patient lives globally.
  • Provide effective oversight of external providers of Pharmacovigilance services.
  • Conduct oversight of vendors to ensure compliant and timely processing of adverse event information.
  • Ensure adherence to global regulations and company standards for quality, compliance, and productivity.

Benefits

  • Paid time off (vacation, holidays, sick)
  • Medical/dental/vision insurance
  • 401(k) to eligible employees
  • Participation in short-term and long-term incentive programs
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