Senior PV Scientist, Doc. Management Specialist

1 week ago


Massachusetts, United States The Fountain Group Full time $120,000 - $180,000 per year

We are currently seeking a Senior PV Scientist, Doc. Management Specialist for a prominent pharmaceutical client of ours. This position is in Remote. Details for the position are as follows:

Job Description:

  • Pay: /hr.
  • Length of Assignment: 8.5 months to start with possibility of extension.
  • 100 percent remote position. No travel required.
  • Will be required to edit, format, and perform quality control (QC) checks of PV documents intended for submission to regulatory agencies.
  • Provide additional PV Scientist Support in accordance with company SOPs and processes.
  • Edit, format, and perform QC checks of PV Aggregate Reports, Safety Topic Reports, and Quality Incident Reports intended for submission to regulatory agencies.
  • Edit and format ad hoc documents as appropriate.
  • Ensure documents are securely maintained and version controlled to maintain the integrity of documents in accordance with our SOPs and processes.
  • Importing of documents to the document management system and formatting documents to comply with submission-ready standards/
  • Perform reviews of hyperlinks and bookmarks on published clinical document.
  • Assist the PV Scientists in various tasks to include: production of biweekly clinical line listings, SAE Reconciliation of clinical trials, biannual review of AE Questionnaires in accordance with current Risk Management Plans.
  • Support the PVRM TA Heads in the maintenance of physician eRoom meeting materials, presentations, and product information files on SharePoint.
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