Team Lead, Pharmacovigilance Safety System
2 weeks ago
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
This position is a member of Global Patient Safety – Pharmacovigilance Compliance and Safety Operations -PV Technology and Systems support team. This position is a Team Lead position and is responsible for supervision of the Systems Support team. This position is responsible for managing systems and databases to support consistent and accurate pharmacovigilance data collection, data analysis, report generation, and submission tracking. This role implements user requirements and acts as a technical expert for managing system requests and updates to codelists and libraries. This position works with internal GPS functional areas as well as vendor resources to review and implement medium to complex change requests including updates to reporting rules.
The team lead ensures that PV Technology and Systems support operations are appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to pharmacovigilance.
Responsibilities include, but are not limited to the following:
Supporting the maintenance of current pharmacovigilance safety system (ARGUS and PVQ). Ability to work flexible hours supporting users in different time zones. May need to work in shifts as needed/assigned. Collaboration with IT teams, Vendor resources to plan and implement system related changes (Routine changes and Change Requests). Initiation, review and notification of routine changes to pharmacovigilance safety system. Review and analysis of user requirements prior to submission and implementation, participate in validation activities as required. Perform periodic review of administrator data including but not limited to user access, company product dictionary and Safety Data Exchange agreements. Ensure that changes made to the databases are controlled through the change control process. Ensure proposed changes to the Pharmacovigilance Safety System are reviewed and validated with GPS functional area prior to processing for implementation Responsible for creating, verifying and tracking complex change requests, including updates to reporting rules, product lists and code lists. Drive consistent interpretation of system related conventions, specifications, and definitions when making any configuration changes Partner in the development of system-related training programs and deliver training Maintain and manage SharePoint sites used for tracking systems requests (Routine changes and Change Requests) Take initiative to recognize, prioritize & escalate potential safety/ compliance issues Train and develop other team members in area of Systems support and database configuration Manage day to day tasks and assignments of team members, be an individual contributor as well as the leader of the teamEscalate any team issues to management as appropriate
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