OVERVIEW : The Senior Safety Associate III will be responsible for supporting Global Case Management with ICSR quality review, controlled document updates and creation, training material edits and creation and associated tasks, and other case processing oversight activities as delegated.

The Senior Safety Associate III supports the Case Processing Oversight and ICSR Processes and GCM Systems teams and is responsible for ensuring AE case processing is compliant with regulatory requirements and corporate and departmental procedures.

JOB DUTIES :

Perform quality review of ICSRs

Monitor case processing workflow for vendors and escalate cases at risk of missing timelines.

Perform review and updates in controlled documents.

Recording meeting minutes and team notes.

Participate in testing and conference room pilots for Global Safety Database (GSD) upgrade project.

Support other tasks as assigned by manager.

REQUIREMENTS :

Bachelor's Degree in nursing, pharmacy, or other health care related profession or life sciences

Must have direct experience with end-to-end Case Processing (data entry and quality review) of both Clinical Trial and Post-marketing ICSRs

Advanced proficiency in Microsoft Office applications

Exceptional organizational skills and attention to detail

Ability to successfully and efficiently multi-task

Excellent communication skills (written and verbal)

Knowledge of common safety database systems

Ability to work collaboratively in a team environment

EEO :