Business Systems Analyst, Drug Safety Information & Systems
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POST DATE 9/18/2016
END DATE 10/23/2016
JOB DESCRIPTIONAPPLY Pharmacyclics, an AbbVie Company, based in Sunnyvale, CA represents the single largest acquisition AbbVie has ever made, and is key to AbbVie s corporate strategy to add another very significant growth platform and diversification. Pharmacyclics will be run as a semi-autonomous, fully integrated operating unit of AbbVie, with all functions including among others Commercial, R&D and Manufacturing. The integration into AbbVie should be minimally disruptive for Pharmacyclics; hence the identity, structures and relative independence will be minimally adapted at this time. The new President of Pharmacyclics is Erik von Borcke, currently a senior executive with AbbVie who has relocated to the Sunnyvale Area and reports to the Chairman and CEO of AbbVie, Rick Gonzalez.
Execute all functions of Drug Safety Systems in meeting Drug Safety and Pharmacovigilance departmental objectives for overall compliance as outlined by the VP, Drug Safety. Reporting to Sr. Manager, Drug Safety and Pharmacovigilance Information & Systems. Performing as an individual contributor in a fast paced, growing organization.
Key Accountabilities/Core Job Responsibilities:
Support the design and implementation of applications to sustain Drug Safety objectives, including Argus Safety, MedDRA, etc.
Application administrator responsible for coordinating quality review of all configuration changes to Argus
Support ad hoc reporting process
Support programming, validation, and generation of reports for data analysis, including US periodic reports and ICH PSUR line listings
Interpret regulatory changes as they impact technology and provide technology expertise to implement regulatory changes for maintaining compliance.
Update and review training documentation for Drug Safety SOPs related to Argus database and data management
Support MedDRA version management and upgrades as required by the Director of Drug Safety Operations
Manage and compile key drug safety case processing and resource requirement metrics
Act as liaison with IT to support delivery of computing infrastructure
Maintain compliance with relevant policies and procedures
Provide technology expertise for the definition and implementation of change initiatives aligned with vision and strategies
Support the resolution of complex, cross-functional issues using strong problem solving abilities