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Job description
We are seeking a detail-oriented and organized PV Systems Support Specialist to provide technical and operational support during an RFP project. This position will support pharmacovigilance (PV) systems, database maintenance, user administration, system validation activities, reporting, ticket triage, training coordination, and day-to-day support for the PV system user community., Database Reporting Support Run routine reports and queries from GPV database tables using SQL as needed. Maintain and update PV system databases and Product Dictionary entries. Create new Product Dictionary entries and perform routine maintenance. Maintain Product Families and Product Lines. Perform Product Family verifications and related data updates. Support dashboard maintenance and monitoring. PV System Support Serve as the first line of support for PV system-related questions and issues. Triage system support tickets and determine appropriate resolution or escalation. Monitor PV systems and collaborate with IT and external vendors to resolve system issues. Support PV system setup and configuration activities. Assist with case type changes and other system updates as assigned. Support new-user setup, including initial system access and login assistance. Maintain system-related mailboxes and support communication with the PV user community. User Training Administration Support training coordination for the PV system user community. Assist with new-user training and onboarding. Assign and maintain required training curricula. Provide frontline assistance and guidance to users navigating PV systems. Communicate system updates, issues, and relevant information to the PV user community. Validation Documentation Support computerized system validation testing in accordance with established procedures. Assist with the review of PV documentation. Support the organization, maintenance, and archiving of PV documentation.
Ensure system and documentation activities are completed accurately and in accordance with applicable procedures. Additional Responsibilities Collaborate effectively with cross-functional teams, including IT, vendors, and PV stakeholders. Prioritize multiple assignments while meeting project deadlines and operational requirements. Perform other duties and special projects as assigned by leadership.
Requirements
The ideal candidate has experience working with GxP computerized systems, familiarity with SQL and databases, strong organizational skills, and the ability to provide effective customer service and technical support in a regulated environment., Experience working with GxP computerized systems. Experience with SQL and database queries. Strong organizational and time-management skills with the ability to prioritize multiple assignments. Ability to work effectively in a team-oriented environment. Strong customer service and communication skills. Strong attention to detail and commitment to data accuracy. Education Associates or Bachelors degree in Information Technology, Business, or a related field required. Preferred Qualifications Experience supporting global systems and users. Experience working in a regulated pharmaceutical, life sciences, or healthcare environment. Experience with computerized system validation (CSV). Experience providing application or system support to end users.
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