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    Senior Safety Associate III - Cambridge, United States - SSi People

    SSi People
    SSi People Cambridge, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    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

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