Safety Systems Analyst II

Job Description

Job Summary:

• Product 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.
• 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.

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.)