Product Safety Coordinator

Product Safety Coordinator

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.

·        Prioritize workload to ensure company and regulatory authority deadlines are met.

·        May include internal and external distribution of information to co-marketing partners, Eisai 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