Safety Systems Analyst
Spectraforce
Princeton, New Jersey
a day ago
Job Description
Job Title: Safety Systems Analyst
Location: Princeton, NJ 08540
Duration: 6 Months
Duties:
Scope of Role Responsible for supporting the Pharmacovigilance (PV) database maintenance. 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
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
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $85.00/hr.
Location: Princeton, NJ 08540
Duration: 6 Months
Duties:
Scope of Role Responsible for supporting the Pharmacovigilance (PV) database maintenance. 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
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
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $85.00/hr.