Drug Safety Admin Associate II Job at Thermo Fisher Scientific, Indiana

  • Thermo Fisher Scientific
  • Indiana

Job Description

Drug Safety Admin Associate II Location Indiana :
  • Coordinates the timely review of serious and non-serious adverse events; tracks all necessary data and generates reports for the client, project team and/or external vendors.
  • Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
  • Manages project training and the set-up archival of files; ensuring PVG remains audit ready.
  • Identifies and redacts subject identifiers per local requirements. retrains sites and escalates to PPD Data Privacy.
  • Performs data entry into internal/external database tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively project timelines.
  • Oversees expenses and manages translations, ensuring budget parameters are not exceeded.
  • Supports any specific activities performed office, which cannot be performed from elsewhere.
  • Provides training to junior staff.
  • In collaboration with Safety Specialist, Medical Monitors and Regulatory Publishing Specialist liaises and establishes effective relationships with internal team members to implement projects, coordinate and facilitate meetings. manage all incoming safety documentation, and accurately manage regulatory documents submissions, filing, and redactions.
  • Provides support and coordination of regulatory publishing documents.
  • Assists in reviewing document quality when tracking regulatory publishing data in internal systems and uploading in internal and/or external electronic trial master files.
  • Ensures redactions for Commercially Confident Information and Personal Data for regulatory publishing is maintained.
  • Assist in maintaining the upkeep of licenses within internal and/or external system for users across projects within IT Security standards.
  • Assist with archiving of regulatory publishing documents and submissions.

Job Tags

Full time, Local area,

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