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Scientific. Clinical. Software Engineering

Sr. Safety Documentation Specialist

New Jersey All, NJ

Job Type: Clinical Job Number: JN -062020-26884 Region: New Jersey All

Job Description

  • Support the Global Patient Safety & Epidemiology (GPSE) team in reviewing files for potential source documentation
  • Review document folders in boxes and sort documents, log/track files, scanning, copying, filing
  • Sort and prepare documentation (i.e. removal of staples, paper clips, etc.), scan the source documents and electronically file them in the allocated location
  • Provide support with document provision/printing/scanning/retrieval and assembly
  • Maintain central repository for electronic documents
  • Monitor group mailbox on a daily basis
  • Prioritize and process documents according to the designated workflow procedure
  • Maintain GPSE trackers, and obtain updates as needed
  • Adhere to source file sign-in/sign-out process, as required
  • Ensure work area is presentable, with all necessary stationery and material (e.g. files, pens, source documents)
  • Provide basic and accurate information in-person and via phone/email, within the scope of job responsibilities, in response to inquiries
  • Provide support for orientation and of new team members on the project

Minimum Job Requirements:

  • Minimum of 3-5 years of pharmaceutical document associate/specialist experience
  • Drug safety document support experience
  • Proficient with electronic systems including, Microsoft Office Suite, Microsoft Visio, Microsoft SharePoint, Adobe Acrobat and Skype
  • Ability to handle and prioritize multiple priorities
  • Self-starter with ability to work independently
  • Ability to work effectively in a team environment

Demonstrated strengths in the following areas:

  • Verbal and written communication
  • Time management
  • Problem solving
  • Attention to detail
  • Interpersonal skills
  • Cross-cultural sensitivity
  • Planning and organization
  • Initiative and accountability


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