Submission Analyst
Submission Analyst
Baxter
Job description
Looking to build a career in drug safety case submissions? Explore this Submission Analyst role at Baxter in Bangalore.
Company Description
Baxter is a healthcare company that was founded in 1931 because Baxter believes that every person deserves a chance to live a healthy life. Baxter’s mission is to save and sustain lives. The company is changing the way healthcare is delivered and is bringing more personal care to patients around the world. Baxter’s culture is built on courage, trust, and strong teamwork.
Job Summary
This role is part of the Safety Submissions team within Global Pharmacovigilance at Baxter in Bangalore. As a submission analyst, you will send individual case safety reports to regulators, affiliates, and business partners by electronic means. Manage the electronic submission rules in the safety database. You will also help fix reports that are not accepted by regulators.
Key Responsibilities
Create and issue regulatory reports, including individual case safety reports.
Run or monitor electronic submissions of ICSRs to regulators, affiliates, or business partners.
Take part in peer review of submissions done by other team members.
Help set up and maintain electronic submission rules by product and recipient in the safety database.
Make sure electronic reporting follows the rules and guidelines that apply.
Share electronic submission knowledge with Safety Operations so adverse events are coded properly.
Work with ICH E2B and HL7 data standards, and keep up with new changes.
Help Safety Operations find and fix E2B rejections so reports are accepted.
Work with regional and country pharmacovigilance teams to send reports to each country contact.
Work with data analysts in PV Technology on database upkeep.
Work with other Baxter groups, such as Clinical and Medical Affairs, Quality, Regulatory, IT, and Legal, on safety data standards.
Educational Qualification
Bachelor's degree in computer science, life sciences, or an equivalent qualification.
Skills Required
One year of experience in safety submissions, pharmacovigilance, regulatory affairs, or clinical research is desired.
Experience in quality assurance, data management, or IT is also useful.
Solid knowledge of pharmacovigilance terms, especially ICH E2B, and data entry rules.
Knowledge of a global safety database.
Ability to work well in a team.
Good technical skills with word processing, spreadsheets, databases, and markup languages.
Knowledge of medical terms.
Salary Structure
The estimated total salary for a Submission Analyst at Baxter in India typically ranges from ₹9 Lakhs to ₹13 Lakhs per year.
Career Development
This role gives you experience in global drug safety reporting. You will send case reports. Set up rules in the safety database. You also get to work with teams across pharmacovigilance, regulatory, quality, and IT groups. It’s a chance to learn by doing and to see how different teams come together to protect safety.
How to Apply
Visit our job portal and search for the Submission Analyst role at Baxter.
Click on the job posting to see all the details about the job.
Enter your information and add your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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