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Safety Systems Analyst II
Location:
Princeton
Description:
Scope of Role Responsible for supporting the maintenance of the Pharmacovigilance (PV) database. Responsible for supporting and performing PV database data retrieval activities. Primary Responsibilities タ Execution of weekly, monthly and ad hoc reports from the PV database タ Preform all required Quality Control (QC) and complete documentation タ Assist with the execution and verification of Ethics Committee and Health Authority Periodic outputs タ Maintain and distribute the Study Configuration Spreadsheet タ Maintain and distribute applicable sections of the Data Entry Conventions and associated appendices タ Track the development, testing, implementation and closure of all PV Systems requests タ Assist PV Systems Director with the following activities: タ maintenance and delivery of systems supporting the PV business unit, the primary focus is the Argus Safety Systems. タ monitoring of PV System vendor activities and ensuring compliance with contractual expectations タ maintaining documentation of system configuration and all subsequent changes タ validates and implements annual, periodic and ad-hoc reports in the Drug Safety systems タ maintaining the processes for systems in compliance with regulatory requirements and company standards Education/Experience/Skills タ At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety Database タ Attention to detail, Critical thinking, Creative problem-solving, Collaborative approach, Proficient Computer Skills, including Microsoft Word and Excel タ Knowledge of Drug Safety and Pharmacovigilance function タ English (fluent verbal and written)Education: At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety Database Supplier FLSA Classification: N/A H-1B: No Job Category: Environmental/Health/Safety Job Category: Environmental/Health/Safety Job Code: 3300.0:Safety Systems Analyst II Skills : Required PROBLEM-SOLVING DRUG SAFETY DATABASE PHARMACOVIGILANCE EXCEL Additional Languages: English( Speak, Read, Write ) Minimum Degree Required: Completed High School (Diploma or GED)
Company:
Aequor
Posted:
June 6 on HireLifeScience
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