Submission Analyst

Zvh; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Baxter is seeking a Safety Submissions professional to join the Global Pharmacovigilance team. You will manage electronic distribution and submission of individual case safety reports (ICSRs) and help set up submission rules in the pharmacovigilance database.

You will collaborate with regional pharmacovigilance counterparts and Safety Operations to ensure compliant reporting, troubleshoot E2B rejections, and support data standards like E2B and HL7 across the organization.

Qualifications

• Solid knowledge of pharmacovigilance terminology, specifically ICH E2B.
• Ability to analyze & resolve problems with analytical & problem solving skills.
• Excellent written & oral communication skills.
• Operates effectively in a team environment.
• Knowledge of medical terminology.

Responsibilities

• Create and issue regulatory reports, including individual case safety reports.
• Run and 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 to facilitate proper coding of AE data (ICH E2B and HL7).
• Assist Safety Operations in troubleshooting E2B rejections to get reports accepted by regulators.
• Interface with regional pharmacovigilance functions andPV Technology for database maintenance.
• Interface with Safety Operations and other GPV functions to process adverse events efficiently & reliably.
• Interface with other Baxter groups regarding safety data standards.

Skills

Pharmacovigilance

ICH E2B

Data analysis

Documentation

Team player

Global PV systems

MS Excel

Databases

MS Word

Education

Bachelors in CS or Life Sciences

Tools

Global PV database

Job description

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.

Summary:

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:

• Create and issue regulatory reports, including individual case safety reports.
• Run and/or monitor electronic submissions of ICDs 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.
• Interface with Safety Operations (document specialists, data coordinators, and safety reviewers) and other functions within Global Pharmacovigilance (GPV) to process adverse events efficiently & reliably.
• Interface 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 & elevate potential safety/compliance issues.

Qualifications:

• 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:

• 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.

Our Mission and Culture

Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.