GPS Systems Manager

Exelixis-posted 3 months ago
$130,500 - $185,000/Yr
Full-time
Alameda, CA
251-500 employees
Professional, Scientific, and Technical Services
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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.

  • 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 CFR 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.
  • 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.
  • 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.
  • 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 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.
  • Seeks feedback to ensure that verbal and written communications are clear and easy to understand.
  • Works collaboratively with team members.
  • Good interpersonal skills and understanding of differing views.
  • Excellent written & oral communication skills.
  • Ability to work with all levels of the organization, both technical and non-technical.
  • Ability to be highly organized, and self-motivated with the capability to prioritize projects and workload.
  • Develops and maintains knowledge of cross-functional products, tools, and data sources.
  • 401k plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • Discretionary annual bonus program
  • Opportunity to purchase company stock
  • Long-term incentives
  • 15 accrued vacation days in their first year
  • 17 paid holidays including a company-wide winter shutdown in December
  • Up to 10 sick days throughout the calendar year
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