Product Safety CoordinatorWednesday, May 8th, 2019
Title: Product Safety Coordinator
Term: Anticipated 1 year
Location: All work is ON-SITE in Bergen County, NJ
- 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.
- 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