The 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.
Qualifications:
• 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 preferred
Education:
• PharmD, nurse or other relevant healthcare or life science discipline.
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