Submissions team within Global Pharmacovigilance and focuses on the electronic distribution and submission of Individual Case Safety Reports (ICSRs), including electronic submission rules and reportability setup in the pharmacovigilance database.
Job Details
| Details | Information |
|---|---|
| Company | Baxter |
| Position | Submission Analyst |
| Location | Bangalore, Karnataka |
| Job Type | Full Time |
| Job Requisition ID | JR – 209534 |
| Application Deadline | October 13, 2026 |
| Department | Global Pharmacovigilance – Safety Submissions |
Position
Submission Analyst
The Submission Analyst will support electronic regulatory submissions of ICSRs, maintain electronic submission rules, troubleshoot E2B rejections, and collaborate with Safety Operations, Pharmacovigilance, Regulatory, Clinical, Quality, IT, Legal, and other relevant teams.
Responsibilities
- Create and issue regulatory reports, including Individual Case Safety Reports (ICSRs).
- Run and monitor electronic submissions of ICSRs to regulatory authorities, affiliates, and business partners.
- Participate in peer review of submissions completed by other team members.
- Support the setup and maintenance of electronic submission rules and reportability by product and recipient in the pharmacovigilance database.
- Support electronic submission intelligence related to AE data coding, including ICH E2B and HL7 data standards.
- Assist Safety Operations in troubleshooting E2B rejections and making necessary corrections for report acceptance.
- Collaborate with regional and country pharmacovigilance functions regarding electronic distribution and submission.
- Work with data analysts and PV Technology teams on database maintenance.
- Collaborate with Safety Operations and Global Pharmacovigilance teams to process adverse events efficiently and reliably.
- Work with Clinical & Medical Affairs, Quality, Regulatory, IT, Legal, and business units regarding safety data standards.
- Identify, prioritize, and escalate potential safety and compliance issues.
- Perform additional responsibilities and projects as assigned.
Eligibility / Qualifications
Candidates should have:
- A Bachelor’s degree in Computer Science, Life Sciences, or equivalent.
- One year of previous experience in Safety Submissions, Pharmacovigilance, Regulatory Affairs, and/or Clinical Research is desired.
- Additional experience in Quality Assurance, Data Management, or IT is relevant.
Required Skills
- Solid knowledge of pharmacovigilance terminology, particularly ICH E2B.
- Knowledge of system data-entry conventions.
- Analytical and problem-solving skills.
- Strong organizational skills and attention to detail.
- Excellent written and oral communication skills.
- Ability to work effectively in a team environment.
- Knowledge of a Global Safety Database.
- Technical system skills, including word processing, spreadsheets, databases, and markup languages.
- Knowledge of medical terminology.
Application Details
