Drug Safety Associate

Drug Safety AssociateThe Safety and Benefit Risk, Global Case Management department performs pharmacovigilance activities, ensuring timely adverse event reporting in compliance with applicable laws and regulations/company policies throughout the lifecycle of products. The candidate will function as an integral part of the Global Case Management team, working under the direction of a manager, to meet department objectives or assist on special projects within established deadlines.Requirement:• Completes Medical Data Entry in the Global Safety Database (GSD), including the generation of medical narratives, and ensures accurate coding in the GSD.• Performs Peer Quality Control to ensure completeness, accuracy, and overall high quality of adverse event data entered into the GSD.• Participates, in data clean-up activities in support of the global safety database migration.• Executes the User Acceptance Testing (UAT) database scripts to ensure accuracy and functionality of the new database.• Assists with ad hoc activities identified following the implementation of the new database.• Assists with testing and executing change request post database migration.• Assists with ad hoc projects.QualificationsQualifications:• Has at least 3+ years of experience in pharmacovigilance.• Current working knowledge of AERS, and/or ARISg Global Safety Databases.• Has post-marketing, observational study, and interventional study case processing experience.• 1+ years of experience with hands on patient care in a clinical setting is preferredEducation:• PharmD, nurse or other relevant healthcare or life science discipline.