Steneral
Safety Analyst II
Steneral, Princeton, New Jersey, us, 08543
3 days onsite each week, must be local and under 60 minsNeed active and Valid LinkedInNeed Visa copy for non USC and photo ID for USC (no info must be hidden/blacked out as they won't be considered)Must be IndependentPossible CTH rolePrimary Responsibilities
Execution of weekly, monthly, and ad hoc reports from the PV databasePerform all required Quality Control (QC) and complete documentationAssist with the execution and verification of Ethics Committee and Health Authority Periodic outputsMaintain and distribute the Study Configuration SpreadsheetMaintain and distribute applicable sections of the Data Entry Conventions and associated appendicesTrack the development, testing, implementation, and closure of all PV Systems requestsAssist PV Systems Director with the following activities:Maintenance and delivery of systems supporting the PV business unit, the primary focus is the Argus Safety Systems.Monitoring of PV System vendor activities and ensuring compliance with contractual expectationsMaintaining documentation of system configuration and all subsequent changesValidates and implements annual, periodic, and ad-hoc reports in the Drug Safety systemsMaintaining the processes for systems in compliance with regulatory requirements and company standardsSkills: Education/Experience/Skills
At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety DatabaseAttention to detail, Critical thinking, Creative problem-solving, Collaborative approach, Proficient Computer Skills, including Microsoft Word and ExcelKnowledge of Drug Safety and Pharmacovigilance functionRequired Skills
PROBLEM-SOLVINGDRUG SAFETYDATABASEPHARMACOVIGILANCE
#J-18808-Ljbffr
Execution of weekly, monthly, and ad hoc reports from the PV databasePerform all required Quality Control (QC) and complete documentationAssist with the execution and verification of Ethics Committee and Health Authority Periodic outputsMaintain and distribute the Study Configuration SpreadsheetMaintain and distribute applicable sections of the Data Entry Conventions and associated appendicesTrack the development, testing, implementation, and closure of all PV Systems requestsAssist PV Systems Director with the following activities:Maintenance and delivery of systems supporting the PV business unit, the primary focus is the Argus Safety Systems.Monitoring of PV System vendor activities and ensuring compliance with contractual expectationsMaintaining documentation of system configuration and all subsequent changesValidates and implements annual, periodic, and ad-hoc reports in the Drug Safety systemsMaintaining the processes for systems in compliance with regulatory requirements and company standardsSkills: Education/Experience/Skills
At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety DatabaseAttention to detail, Critical thinking, Creative problem-solving, Collaborative approach, Proficient Computer Skills, including Microsoft Word and ExcelKnowledge of Drug Safety and Pharmacovigilance functionRequired Skills
PROBLEM-SOLVINGDRUG SAFETYDATABASEPHARMACOVIGILANCE
#J-18808-Ljbffr