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Aggregate Safety Project Specialist

Edison-New Brunswick Metro Area, New Jersey

Post Date: 01/23/2017 Job ID: JN -012017-18175
  • Project Specialist, Aggregate Safety Reporting. (This is a junior level project manager position and candidate can be entry level depending upon work experience).
    -BA or BS in a relevant major (health science, business)
    Scheduling and resource planning of aggregate safety reports (ASRs); Issue escalation
    Job Description:
    To manage, plan and document the schedule of activities for ASRs for development and marketed products; To identify resrources for ASR preparation; To support the communication and actions pertaining to ASRs; Ensure structure and coordination of ASRs; Facilitate ASR reviews; Incorporate Quality throughout the ASR process

    Key Activities:
    -Manage and facilitate Aggregate Report production activities across Global Drug Safety Risk Management and entire Global Safety Network including PSURs; US PSRs, DSURs and other reports as required
    -Manage project schedules
    -Ensure synchronization among ASRs as necessary
    -Track receipt of contributions for ASRs
    -Track and prioritize due dates of ASRs
    -Manage, plan, schedule and coordinate kick-off, strategy and comment resolution meetings
    -Manage, plan, schedule and coordinate time and resources needed for ASR creation
    -Identify all personnell involved in ASR preparation prior to strategy meeting
    -Co-lead ASR strategy meetings
    -Lead ongoing ASR production meetings
    -Create workflows for each of the ASRs in the document management system
    -Ensure contributiors are maintaining compliance with project schedules
    -Schedule additional meetings as needed to resolve issues
    -Collaborate on drafting of key SOPs and WPs related to ASR processes
    -Perform other activities as needs arise in the context of ASRs

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