GPS; PV​/Drug Safety Systems Manager

Position: GPS (PV / Drug Safety) Systems Manager
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.
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* SUPERVISORY RESPONSIBILITIES:

** No supervisory responsibilities.
** EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

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* 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.
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* 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.
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* 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…