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Project Specialist, Aggregate Safety Reporting - Pharma
Ref No.: 20-00541
Location: Summit, New Jersey
Job Description:
  • To manage, plan and document the schedule of activities for aggregate safety reports (ASRs) for development and marketed products.
  • To identify resources 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.
  • Manage and facilitate aggregate report production activities across Worldwide Patient Safety 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; take minutes; distribute minutes.
  • Manage, plan, schedule and coordinate time and resources needed for ASR creation.
  • Identify all personnel involved in ASR preparation prior to strategy meeting.
  • Schedule and Co-lead ASR strategy meetings.
  • Lead ongoing ASR production meetings.
  • Create and manage workflows for each of the ASRs in the document management system.
  • Ensure contributors are maintaining compliance with project schedules.
  • Manages and maintains ASR team SharePoint site.
  • Manages and maintains ASR team mailbox (Outlook).
  • 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.
  • Scheduling and resource planning of ASRs; Issue escalation.

  • Experience with project planning (MS Project) is desirable.
  • MUST HAVE EXCELLENT communication skills - verbal, written, listening. This includes but is not limited to excellent use of English grammar, spelling, punctuation, etc.
  • MUST BE A logical / critical thinker.
  • Experience in pharmaceutical industry operations (eg clinical operations or drug safety operations) or a regulated atmosphere is preferred
  • BA or BS in a relevant major (health science, business).