Join Baxter at the intersection of saving and sustaining lives! This is your chance to contribute to global healthcare by ensuring safety and compliance within the pharmacovigilance domain. The role of Submission Analyst offers you the opportunity to participate in the electronic submission of safety reports, enhancing patient outcomes worldwide.

Company Introduction

Baxter is a global leader in providing innovative medical products and therapies that are found in almost every hospital, clinic, and home worldwide. With over 85 years of pioneering advancements, Baxter is dedicated to improving healthcare outcomes for millions of patients. At Baxter, your work can accelerate the company’s mission to save and sustain lives.

Responsibilities in the Job

As a Submission Analyst, you will:

1. Regulatory Reporting
   • Create and issue individual case safety reports (ICSRs) to regulatory authorities and business partners.
   • Monitor electronic submissions for compliance with global regulations.
2. Database Maintenance
   • Set up and maintain electronic submission rules and product-specific reporting guidelines in the pharmacovigilance database.
   • Provide electronic submission intelligence to ensure proper coding of adverse event data.
3. Troubleshooting and Compliance
   • Assist in resolving E2B rejections and making corrections for regulatory acceptance.
   • Collaborate with regional pharmacovigilance functions to ensure seamless electronic distribution.
4. Collaboration
   • Interface with internal teams, including Safety Operations, IT, Regulatory, and Quality Assurance.
   • Support global safety database management and ensure adherence to safety data standards.
5. Continuous Improvement
   • Proactively identify and escalate potential safety or compliance issues.
   • Participate in peer reviews and additional projects to enhance efficiency and compliance.

Qualifications

To qualify for the role of Submission Analyst, you should have:

• Education:
  • Bachelor’s degree in computer science, life sciences, or a related field.
• Experience:
  • At least 1 year of experience in safety submissions, pharmacovigilance, regulatory affairs, or clinical research (preferred).
  • Additional experience in quality assurance, data management, or IT is beneficial.
• Skills:
  • Knowledge of pharmacovigilance terminology (ICH E2B).
  • Proficiency in global safety databases.
  • Analytical problem-solving skills.
  • Strong organizational skills and attention to detail.
  • Excellent written and verbal communication abilities.

Application Link