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Data Assurance Associate (GPV)

Northbrook, IL 60062

Posted: 09/19/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 585393 Is job remote?: Yes Country: United States

Job Description

Pay 50-60/h depending on experience

  • Communicates with internal and external parties on case content and replies to case-related queries.
  • Makes decisions on case processing matters for prioritization, FU significance, seriousness, listedness, coding queries, etc.
  • Initiates case corrections, as needed.
  • Approves case corrections, as needed
  • Supports late case investigations by PV COPE team
  • Performs clinical open query investigations
  • Provides support for the creation/update of training materials in collaboration with the Data Assurance Manager and PV Training team.
  • Assists in facilitating finalized training sessions (PV processes and systems) for vendors and relevant case processing staff in collaboration with the Data Assurance Manager and PV Training team.
  • Provides support to global Data Assurance teams and other internal departments, as appropriate

Skill Set Required:
  • BS degree in life sciences or equivalent (RN preferred)
  • 5+ years relevant experience within Pharmacovigilance
  • Knowledge and understanding of PV regulatory requirements and ICSR processing procedures globally and in Americas region
  • Has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
  • Present solutions to problems that require the regular use of creativity and ingenuity, while safeguarding company compliance.
  • Ensures case processing and case quality are maintained at highest standards at all times
  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to develop effective relationships through collaboration.
  • Good communication skills in English (written and spoken)
  • Ability to work independently in seeking materials needed for completing daily tasks.
  • Ability to work in a fast-paced environment.

Skill Set Bonuses
  • Working knowledge of ARGUS safety database
  • Experience with Word, Excel, PowerPoint, Microsoft Teams and SharePoint sites
  • Experience with working from home
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