Drug Safety Associate

Title: Senior Safety Associate (Global Case Management) 

Location: Cambridge, MA

Duration: 8 - 12 Months+

Job Summary 

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.