Submission Analyst

Baxter International Inc.; Bengaluru; Sur place; INR 600 000 - 900 000; Plein temps

Résumé du poste

Baxter International Inc. is seeking a Safety Submissions Specialist to manage electronic distribution and submissions of individual case safety reports (ICSRs) within Global Pharmacovigilance. You will configure submission rules, ensure compliance, and collaborate with regional teams.

The role requires ICH E2B knowledge, strong analytical skills, and experience with safety databases. Prior pharmacovigilance exposure is desirable; bachelor’s degree required.

Qualifications

• Knowledge of ICH E2B and data entry conventions.
• Analytical and problem-solving capabilities.
• Strong organization and attention to detail.
• Excellent written and oral communication.
• Ability to operate effectively in a team.
• Knowledge of Global Safety Database systems.
• Technical skills: word processing, spreadsheets, databases, markup languages.
• Knowledge of medical terminology.

Responsabilités

• Create and issue regulatory reports, including individual case safety reports.
• Run and monitor electronic submissions of IC SRs to regulators, affiliates, or partners.
• Participate in peer reviews of submissions.
• Support setup and maintenance of electronic submission rules and reportability in the pharmacovigilance database.
• Assist in providing electronic submission intelligence for proper AE data coding (E2B/HL7).
• Troubleshoot E2B rejections to achieve acceptance by authorities.
• Interface with regional pharmacovigilance, PV Technology, Safety Operations, and other groups on safety data standards.
• Take initiative to recognize and elevate safety/compliance issues.
• Additional responsibilities as assigned.

Connaissances

ICH E2B knowledge

Analytical/problem solving

Attention to detail

Written & verbal communication

Teamwork

Global Safety Database knowledge

Technical system skills

Medical terminology

Formation

Bachelor’s degree in computer science or life sciences

Description du poste

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:

(optional)

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 IC SRs 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 & elevate 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:

N/A: Intern or Co-op

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.

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.