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Drug Safety Pharmacovigilance Specialist

Company: Spectrum Pharmaceuticals, Inc.
Location: Irvine
Posted on: May 3, 2021

Job Description:

Summary:

The individual in this position conducts case processing activities for Spectrum's clinical and commercial drug and biologics products to support product safety and compliance with global drug safety regulations and departmental procedures.

Responsibilities:

  • Receives safety related information from all sources, including clinical trial cases, spontaneous reports, and literature reports (U.S. and global).
  • Performs triage for incoming cases, considering assessments of seriousness, listedness, and causality.
  • Performs accurate data entry into the safety database.
  • Conducts MedDRA coding.
  • Prepares high quality case narratives, including identifying relevant information from source documents.
  • Produces accurate safety reports (i.e. CIOMS/MedWatch Forms) for submission to regulatory authorities and partners.
  • Tracks due dates for partner submissions.
  • Conducts reconciliation activities with partners.
  • Conducts peer review of cases in the safety database for quality control.
  • Produces queries as needed for clarification of clinical reports.
  • Conducts active follow-up, including written and verbal follow-up.
  • Conducts reconciliation of the safety and clinical databases for serious adverse events.
  • Supports the management of case processing deadlines.
  • Extracts data from the safety database, as needed.
  • Compiles safety information for aggregate safety reports and other safety related reports
  • Conducts departmental specific projects as needed.

Required Skills, Education and Experience:

  • A degree in a healthcare discipline is required (e.g. pharmacist, nurse, physician).
  • Minimum of one year of safety experience in the pharmaceutical industry.
  • Understands local and applicable foreign safety regulations.
  • Strong clinical background, with ability to interpret medical records (e.g. laboratory results, medical conditions).
  • Experience with use of safety databases, preferably Argus Safety Database.
  • Strong written communication skills, with ability to write clearly and concisely.
  • Attention to detail and the ability to prioritize.
  • Time management skills with ability to prioritize to meet required deadlines.
  • Ability to collaborate with team members.

Availability:

  • Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel:

  • Position is located in United States (Irvine, CA or Cambridge, MA).
  • Position may require occasional travel.

Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

Keywords: Spectrum Pharmaceuticals, Inc., Irvine , Drug Safety Pharmacovigilance Specialist, Other , Irvine, California

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