Product Safety Coordinator

Title: Product Safety Coordinator

Term: Anticipated 1 year

Location: All work is ON-SITE in Bergen County, NJ

Job Description:

  • Receipt and triage of adverse event reports for marketed and investigational products from all sources.
  • Preliminary evaluation of clinical trial, spontaneous (post-marketing), and solicited reports of adverse events, including communication with partners and affiliates when necessary to verify completeness and accuracy.
  • Case preparation – duplicate searches, initial data entry, and assignment of cases to Specialists. Particular emphasis is placed on determination of seriousness, expectedness, and validity.
  • Prioritizes workload to ensure Company and Regulatory Authority deadlines are met. May include internal and external distribution of information to co-marketing partners, affiliate offices, and others as requested.

 

Requirements:

  • Bachelor’s degree required, preferably in a scientific or medical discipline
  • Previous experience in data coding and retrieval skills using database technology
  • Knowledge of medical terminology
  • Prior work experience in Product Safety/Pharmacovigilance preferred
  • Precise attention to detail and ability to multi-task
  • Good communication skills, both written and verbal
  • Ability to work independently, and as part of a team
  • Accepted file types: doc, pdf, txt, docx.