- Accurately performed data entry of domestic and foreign serious and non-serious adverse event information into the Product Safety data base with the ARISg coding manual, SOPs/WIDs
- Full understanding of the products' Company Core Data sheet, PI, for accurate labeling and listedness
- Maintain proficiency in the utilization of the PSSS, including MedDRA coding
- Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within the company and regulatory timeframes
- Utilized ARISg for all reporting and confirmation of successful distribution and acknowledgement
- Perform appropriate and timely follow-up, including accurate and thorough documentation within the case
- Maintain sufficient knowledge of all Eisai products to perform accurate product information in response to queries
P
Propharma Group
Pharmacovigilance Specialist
January 2021 - December 2022
P
Positive Impact Health Centers
Clinic Nurse Manager
Duluth, GA, US
August 2021 - May 2022
P
PCG
Registered nurse lead
March 2021 - July 2021
Skills
Languages
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Skills
Active Listening SkillsAdvanced Cardiovascular Life Support (ACLS)Analytical ThinkingAttention to DetailBotulinum ToxinCardiologyCertified Nurse PractitionerClinical Laboratory Improvement AmendmentsClinical WorksCommunication SkillsConflict ResolutionConstruction ManagementCore DataDatabasesData Entry SkillsDatasheetsDetection TheoriesElectronic Medical RecordsEmergency ManagementHealth AdministrationHealth Insurance Portability and Accountability Act ComplianceHivInfectious DiseasesInnovationInterpersonal SkillsISO 13485LabelingLife SupportMarketingMaterial Safety Data SheetsMedDRAMedical MaterialsMedical TerminologyMedical TestsNetworking SkillsNursingOccupational Safety and HealthPharmaceuticalsPharmacovigilanceProduct Information ManagementPublic HealthRegulatory AffairsRegulatory RequirementsSafety PrinciplesTesting SkillsTriageWireless Intrusion Prevention Systems