Submission Analyst

This is where  your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.  Your Role at Baxter: This position is a member of the Safety Submissions team within Global Pharmacovigilance and is responsible for electronic distribution and submission of individual case safety reports (ICSRs). This includes maintaining and setting up electronic submission rules in the pharmacovigilance database. What you’ll be doing This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned. Create and issue regulatory reports, including individual case safety reports. Run and/or monitor electronic submissions of individual case safety reports (ICSRs) to Regulatory Authorities, affiliates, or business partners as appropriate Participate in peer review of submissions performed by another member of the team. Support set up and maintenance of electronic submission rules and reportability by product and recipient in the pharmacovigilance database to ensure electronic reporting is performed in compliance with applicable regulations and guidelines. Assist in providing electronic submission intelligence to Safety Operations in order to facilitate proper coding of electronic exchange (AE) data. This covers International Council for Harmonisation (ICH E2B) and HL7 data standards as well as future developments in that area. For ease of reference, they are all referred to as E2B in this document. Assist Safety Operations in troubleshooting E2B rejections in order to make the necessary corrections to get reports accepted by the applicable regulatory agencies. Interface and collaborate within the scope of these responsibilities with relevant counterparts in the regional & country pharmacovigilance functions to facilitate electronic distribution/submission to each country contact. with data analysts and other functions within Pharmacovigilance Technology in all aspects of database maintenance. with Safety Operations (document specialists, data coordinators, and safety reviewers) and other functions within Global Pharmacovigilance (GPV) to process adverse events efficiently & reliably. with other Baxter groups (e.g. Clinical & Medical Affairs, Quality, Regulatory, IT, Legal, business units,…