Drug Safety Reporting Specialist

Orsini HealthcareElk Grove Village, IL
22h$55,000 - $58,000Hybrid

About The Position

The Drug Safety Reporting Specialist will ensure accurate and timely completion of daily adverse event and product complaint documentation to ensure compliance with manufacturer reporting requirements. This role will require understanding of the reporting requirements, investigation of the event, meticulous attention to detail, and preparation of the event reports for on time submission of all reports to our manufacturers.

Requirements

  • Prior experience with Adverse event and product quality complaint reporting preferred.
  • Ability to gather information from medical records and patient notes and enter into adverse event and product complaint forms that meet manufacturer requirements.
  • Proficiency with Microsoft products, including Word, Excel, and Power Point, as well as Adobe Acrobat.
  • Ability to prioritize, multi-task, and manage very time sensitive tasks effectively to meet strict deadlines.
  • High degree of accuracy and attention to detail.
  • Excellent written and verbal communication skills.
  • Pro-active with good analytical skills and problem-solving ability.
  • Self-directed individual with ability to work independently with minimal supervision.
  • Ability to work collaboratively and productively with co-workers across the organization.
  • Familiarity with pharmacy industry and/or previous pharmacy experience preferred.

Nice To Haves

  • Prior experience with Adverse event and product quality complaint reporting preferred.
  • Familiarity with pharmacy industry and/or previous pharmacy experience preferred.

Responsibilities

  • Complete adverse event and product quality complaint forms for submission each day to comply with manufacturer requirements.
  • Assist with investigation of adverse events as assigned
  • Respond to follow up inquiries from manufacturers regarding adverse event and product complaint reports submitted; provide additional information as requested.
  • Assist with weekly, monthly, and quarterly adverse event and product complaint reconciliation as required by manufacturers.
  • Other compliance related duties as assigned by manager

Benefits

  • Medical Coverage, Dental, and Vision Coverage
  • 401(k) with employer match
  • Accident and Critical Illness coverage
  • Company-paid life insurance options
  • Generous PTO, paid holidays, and floating holidays
  • Tuition reimbursement program.
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