GPS; PV​/Drug Safety Systems Manager

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SUMMARY/JOB PURPOSE

Drug Safety Systems Associate III will report to the Director of Global Patient Safety Systems and be responsible for serving as a system functional expert on the Safety applications and responsible for creating and generating various reports, including aggregate reports for GPS operations and risk-benefit teams. This position is mainly responsible for supporting the analytical requirements of the GPS organization.

Essential Duties/Responsibilities

• Responsible for the development, validation, and generation of reports for data analysis, periodic reports, ICH PSUR/DSUR line listings, and ad-hoc queries.
• Create custom and ad hoc queries to extract data from the system and apply a quality control procedure to ensure correctness and completeness to the listings.
• Create or improve processes for data extraction, management, and quality control.
• Assist in implementing and managing the effective structure, procedures, and tools to ensure aggregate reports and other deliverables are completed with high quality.
• Assist with developing and maintaining GPS systems SOP, Procedures, Forms, Work Instructions, and guidance documents, and conduct periodic reviews and update as necessary.
• Closely work with GPS business team members to gather requirements and oversee the implementation of the technical solutions to the requirements.
• Work with GPS business to help define and document business processes and system requirements.
• Participate in GPS systems validation and UAT activities adhering to 21 CFGR Part 11 guidelines.
• Assist in evaluating the technical and analytical needs of the GPS department and maximize the capabilities of the safety and other GPS-related systems.
• Liaison between Global Patient Safety, QA, IT & Digital Transformation teams.
• Assist in the preparation and support of audits and inspections.
• Understand regulatory changes as they impact the organization.
• Coordinate with new initiatives and participate in implementing new tools and technology solutions.
• Work with GPS business to help define and document business processes and system requirements.
• Participate in GPS systems validation and UAT activities adhering to 21 CFR Part 11 guidelines.
• Participate in analyzing and performing impact assessment on the change requests, initiate change controls and oversee implementation.
• Oversee development and maintenance of safety systems configurations.
• Oversee vendor activities and their deliverables.
• Perform additional tasks as needed or assigned to meet the needs of the team, and to support GPS business needs.
• Participate in analyzing and performing impact assessment on the change requests, initiate change controls and oversee implementation.
• Oversee MedDRA & WHO drug dictionaries, Axway E2B Gateway transactions and resolve any issues working with IT/Digital and business team members.

Supervisory Responsibilities

No supervisory responsibilities.

Education

• BS/BA degree in a related discipline and seven years of related experience; or,
• MS/MA degree in a related discipline and five years of related experience; or,
• PhD in a related discipline and zero years of related experience; or,
• Equivalent combination of education and experience.

Experience

• Significant experience in pharmacovigilance with a proven record of supporting safety tools/solutions, preferably Argus, Axway and other PV-related systems.
• Significant experience with analytical and business intelligence tools, preferably PV Reports or equivalent.
• Experience with RDBMS and SQL/PL-SQL programming.
• Experience in GxP Computer system process.
• Experience with SDLC, OnPrem, and SaaS deployment models.

Knowledge,

Skills And Abilities

• Knowledge of biotechnology/pharmaceutical sector.
• Knowledge of regulatory framework governing patient safety.
• Adopts an analytical approach to solve problems relevant to the role.
• Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work.
• Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.
• Seeks feedback to ensure that…