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.
...Server - AM The core duties and responsibilities of the Server - AM include: Set the food and beverage stations according to... ...experience in an operation with considerable guest contact. Bartending experience - knowledge needed. Ability to follow hotel food...
Canvas Dallas Hotel - Safety & Security Officer Address 1325 Botham Jean Boulevard, Dallas, TX, 75215, USJoin our team as a Safety & Security Officer. As a Safety & Security Officer, youre more than just a watchful eye youre the calm, confident presence that helps...
...broader Marketing team as needed. What You Bring: ~13 years of experience in Marketing, Communications, Business, Creative, Advertising, or an Administrative/Executive Assistant role; internships or early career experience within a consumer brand are a plus. ~ A...
...our team. The ideal candidate will have a strong background in food handling, meat cutting, and food preparation, with a focus on delivering... ...meat cutting techniques are essential Experience in the food industry, especially in meat cutting or food handling roles, is highly...
...Enterprise Operations & Risk - Middle and Back Office Oversight - Investment Management Senior Consultant Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that...