Drug Safety/Medical Information Specialist is responsible for collecting, monitoring, processing, and distributing adverse event reports and information queries for investigational and marketed products. Reviews safety and medical information for the assigned products, including safety components of protocols and studies for assigned drugs. Being a Drug Safety/Medical Information Specialist may require a bachelor's degree in area of specialty. Typically reports to a supervisor or manager. To be a Drug Safety/Medical Information Specialist typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)
Experience processing Oncology cases
Have demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance related to pharmacovigilance and Good Clinical Practices
Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge
Competence with commercial safety application databases such as Clintrace, ArisG or Argus. Knowledge of clinical trial database (e.g., Trailmaster) is a plus
Ability to work effectively as an individual contributor and as project team safety representative
0 Drug Safety/Medical Information Specialist jobs found in Salem, MA area