Clinical Operations

  • location: Northbrook, IL
  • type: Contract
  • salary: $55 - $60.81 per hour

job description

Clinical Operations

Job Title: Data Assurance Associate (GPV)

Position Responsibilities

  • Communicates with internal and external parties on case contents, and to reply to related queries
  • Makes first line decisions on case processing matters for prioritization, FU significance, seriousness, listedness, coding queries, etc
  • Performs or initiates case corrections, as needed
  • Performs SME services for ICSR processing queries by the vendor
  • Supports late case investigations by the regional PV Process Governance team.
  • Provides Subject Matter Expertise (medical/technical.) for the creation of training materials in collaboration with the PV Training team.
  • Facilitates finalized training sessions (PV Processes and systems) for vendors and PV Process staff in collaboration with PV Training team.
Position Requirements

  • MS degree in life sciences or equivalent (RN preferred)
  • 5+ years relevant experience; medical assessment experience and expertise within Pharmacovigilance
  • In-depth knowledge and understanding of PV Process regulatory requirements and ICSR processing procedures globally and in Americas region
  • A technical expert within the organization, with extensive knowledge within their chosen specialty and developing knowledge of related disciplines. Has the ability to recommend enhancements to internal policies,
  • processes and procedures based on new requirements, legislation, etc.
  • Provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding Company's 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)
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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