Submission Analyst

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary:

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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.

Essential Duties and Responsibilities:

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 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 AE data. This covers 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 PV 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, etc), specifically in regards to safety data standards.
• Take initiative to recognize, prioritize & escalate potential safety/ compliance issues
• Additional responsibilities and projects as assigned

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

  N/A:  Intern or Co-op

• Solid knowledge of pharmacovigilance terminology, specifically 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

Education and/or Experience:

Include the education and/or experience that is necessary to perform the job satisfactorily.

  N/A:  Intern or Co-op

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  N/A:  Intern or Co-op

• 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.

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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