Safety Systems Analyst II
502 Carnegie Center Drive, Suite 300, R&D Center Princeton, NJ 08540 US
Job Description
*Depending on experience
 Duties: 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 • Execution of weekly, monthly and ad hoc reports from the PV database • Preform all required Quality Control (QC) and complete documentation • Assist with the execution and verification of Ethics Committee and Health Authority Periodic outputs • Maintain and distribute the Study Configuration Spreadsheet • Maintain and distribute applicable sections of the Data Entry Conventions and associated appendices • Track the development, testing, implementation and closure of all PV Systems requests • Assist 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 expectations • maintaining documentation of system configuration and all subsequent changes • validates and implements annual, periodic and ad-hoc reports in the Drug Safety systems • maintaining the processes for systems in compliance with regulatory requirements and company standards Skills: 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 Database • Attention to detail, Critical thinking, Creative problem-solving, Collaborative approach, Proficient Computer Skills, including Microsoft Word and Excel • Knowledge of Drug Safety and Pharmacovigilance function • 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
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