Exelixis · 2 weeks ago
Global Patient Safety Systems Manager
Alameda, CA
Full-time
Onsite
Mid, Senior Level
$130K/yr - $185K/yr
5+ years expExelixis is a biotechnology company focused on innovative cancer therapies, and they are seeking a Global Patient Safety Systems Manager. This role is responsible for serving as a system functional expert on Safety applications, creating and generating reports, and supporting the analytical requirements of the Global Patient Safety organization.
BiotechnologyHealth CarePharmaceutical
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 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
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
Qualification
Required
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
Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals
Seeks feedback to ensure that verbal and written communications are clear and easy to understand. Keeps management informed of potential issues in a timely manner
Works collaboratively with team members
Good interpersonal skills and understanding of differing views
Trains on the process and tools for the role and receives ongoing coaching and/or mentoring by department peers
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
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive 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
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
2026-01-18
2026-01-12
Company data provided by crunchbase