Submission Analyst

Bangalore, Karnataka, INFull-time2026-10-06 → 2026-10-07

Core

Electronic distribution and submission of individual case safety reports (ICSRs) and maintenance of submission rules within the pharmacovigilance database.

Role type

Safety Submission Analyst

Builds

Regulatory safety reports and electronic ICSR submissions to authorities and partners

Domain

Healthcare / Pharmacovigilance

Required skills

ICH E2B standards, HL7 data standards, pharmacovigilance terminology, database maintenance, regulatory reporting, problem-solving, medical terminology (via careerplan.io/jobs/JR-209534-submission-analyst-at-baxter)

Preferred skills

Quality assurance, data management, IT

Technologies

Pharmacovigilance databases, word processing, spreadsheets, markup languages

Responsibilities

Create and issue regulatory reports including ICSRs; Run and monitor electronic submissions to Regulatory Authorities; Participate in peer review of submissions; Support setup and maintenance of electronic submission rules; Assist in troubleshooting E2B rejections; Interface with regional pharmacovigilance functions and Safety Operations

Seniority

Entry-level / Junior

About Baxter

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.