Remote Data Assurance Associate (GPV)
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, labeling, 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 Case Management 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.
- MS degree in life sciences or equivalent (RN preferred)? 5+ years relevant experience; ICSR case processing (PV case processing) 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 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)
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