About this role
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:
• Create, review, and issue regulatory safety reports, including Individual Case Safety Reports (ICSRs), in compliance with global pharmacovigilance requirements. • Execute and monitor electronic submissions of ICSRs to regulatory authorities, affiliates, and business partners, ensuring timely and accurate reporting. • Participate in peer reviews of safety submissions to maintain data quality and regulatory compliance. • Maintain and support electronic reporting configurations, submission rules, and reportability settings within the pharmacovigilance database. • Support the implementation and maintenance of electronic reporting standards, including ICH E2B and HL7 data exchange requirements. • Troubleshoot electronic submission issues and E2B rejections, working with Safety Operations and stakeholders to ensure successful report transmission. • Collaborate with global and regional pharmacovigilance teams to facilitate electronic regulatory submissions and distribution of safety reports. • Partner with Pharmacovigilance Technology teams on database maintenance, reporting processes, and system enhancements. • Work closely with Safety Operations, Regulatory Affairs, Quality, IT, Legal, and other cross-functional teams to support efficient and compliant adverse event reporting. • Identify, assess, and escalate potential safety, quality, or compliance risks in a timely manner. • Contribute to process improvements, special projects, and other pharmacovigilance activities that support business and regulatory objectives. • Ensure all assigned activities are performed in accordance with applicable regulations, company procedures, and quality standards. What you’ll bring
• Solid knowledge of pharmacovigilance terminology, specifically International Council for Harmonizations (ICH E2B), and system data entry conventions • Capacity to analyze & resolve problems with analytical & problem-solving skills • Strong organizational skills with strong attention to detail • Excellent written & oral communication skills • Operates effectively in a team environment • Global Safety Database knowledge • Solid Technical system skills (e.g. word processing, spreadsheet, databases, and markup languages) • Knowledge of medical terminology
• Bachelor's degree in computer science, life sciences or equivalent • One year of previous experience in Safety Submissions or other area of pharmacovigilance, regulatory affairs and/or clinical research is desired. • Additional job experience in the following areas is relevant: quality assurance, data management, or IT.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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