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Information Management Consultant, Pharmacovigilance Information Management

The Information Management Consultant position is a key role in the Pharmacovigilance Information Management group which is primarily responsible for managing the deployment, validation, and maintenance of BioMarin’s safety system and other technologies associated with PV activities for both investigational and marketed products.  The Information Management Consultant is responsible for various PV activities including safety database configuration, electronic data transfer configuration and monitoring, database query generation (SQL), and validation documentation authoring and execution.

 

  • Participate in the design, utilization and management of PV systems with the goal of standardizing and automating PV processes, and ensuring system quality.
  • Assists with PV IM strategic planning, goals and objectives, and execution of assigned PV IM activities.
  • Assist in the development and prioritization of user and functional requirements in collaboration with other PV groups and applicable BioMarin departments.
  • Participate in the continual improvement of PV system processes (e.g., regulatory submissions, data mining and extraction, case workflow).
  • Generate individual case and aggregate safety data reports (via SQL, Argus, and third-party visualization/analytic tools) to support data extraction and analysis.
  • Generate/locate required data/documentation during regulatory authority inspections.
  • Initiate, lead, and manage minor PV systems-related projects including project planning, document management, and resource/vendor management, when applicable.
  • Participate on IT-related projects to assess technology needs and develop strategies and solutions for complex business issues.

Develop and maintain PV IM related written procedures to reflect evolving best practices.

  • Minimum 2 years of related experience, consisting of Project Management, Computer System Validation, and Pharmacovigilance experience.
  • Knowledge of pharmaceutical research and development, global PV regulations, and ICH and GXP Guidelines.
  • Experience working with relational databases (Oracle desired).   
  • Experience with the extraction and presentation of data from safety systems (Argus Safety desired).  SQL experience required.
  • Understanding of PV system requirements, RFPs, systems evaluations, and PV systems. 
  • Understanding of global electronic transmission of safety data to regulators and business partners.
  • Experience assessing and implementing tools and systems to enhance technology based infrastructure for a business unit.

Bachelor’s Degree (in Computer Science or Business-related field desired)

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