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Product Safety Specialist
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Full-time
- Codes and enters information into the global safety database.
- Accurate and timely data entry of both domestic and foreign adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow.
- Full understanding of the products’ Company Core Data sheet, PI, and/or IB for accurate labeling and listedness.
- Maintain proficiency in the utilization of the PSSS, including MedDRA coding.
- Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer.
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