Pharmacovigilance Systems Team Lead
2 weeks ago
Revolutionizing Kidney Care with Baxter
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company, Vantive, built on our legacy in acute therapies and home and in-center dialysis. Vantive will provide best-in-class care to the people we serve, driven by a community of focused, courageous individuals who improve patients' lives worldwide.
This position is a member of Global Patient Safety – Pharmacovigilance Compliance and Safety Operations - PV Technology and Systems support team. As a Team Lead, you will supervise the Systems Support team, responsible for managing systems and databases to support consistent and accurate pharmacovigilance data collection, data analysis, report generation, and submission tracking.
Key responsibilities include:
- Supporting the maintenance of current pharmacovigilance safety system (ARGUS and PVQ).
- Collaborating with IT teams and vendor resources to plan and implement system-related changes.
- Initiating, reviewing, and notifying routine changes to pharmacovigilance safety systems.
- Reviewing and analyzing user requirements prior to submission and implementation.
- Performing periodic review of administrator data, including user access, company product dictionary, and Safety Data Exchange agreements.
- Ensuring changes made to the databases are controlled through the change control process.
- Participating in the development of system-related training programs and delivering training.
- Maintaining and managing SharePoint sites used for tracking systems requests.
This role requires a technical expert who can manage system requests and updates to codelists and libraries, working with internal GPS functional areas and vendor resources to review and implement medium to complex change requests.
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