Data Assurance

Title: Data Assurance

Location: Northbrook, IL

Job Type: Long Term Contract

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.

Required Skills:

• 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 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)