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Safety Systems Analyst

1-2 years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.tech/B.E./BCS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Systems Analyst
Location: Bengaluru, Karnataka, India
Department: GST Operations
Employment Type: Full Time


Company Overview:

At Baxter, every role contributes to a greater purpose—saving and sustaining lives. With over 85 years of healthcare innovation, Baxter’s products are used in hospitals, clinics, and homes across the globe. Join a mission-driven organization where your work truly matters.


Position Summary:

The Safety Systems Analyst is part of the Global Patient Safety (GPS) – Technology, Systems Support team. This role manages pharmacovigilance systems and databases, ensuring accurate data collection, analysis, reporting, and submission tracking. You’ll work closely with internal GPS teams and vendors to implement medium to complex system change requests, reporting updates, and compliance configurations.


Key Responsibilities:

System Support & Maintenance:

  • Maintain and support pharmacovigilance systems (e.g., ARGUS).

  • Work with cross-functional teams to implement system updates and routine changes.

  • Analyze user requirements, support system validation, and manage change control processes.

  • Review and manage administrative data such as user access and product dictionaries.

Data Management & Reporting:

  • Handle change requests including updates to reporting rules, code lists, and product data.

  • Use SharePoint for tracking system changes and requests.

  • Act as a backup for data analysts to generate reports from safety systems.

Compliance & Quality:

  • Ensure system changes follow proper validation and review protocols.

  • Escalate and address potential safety or compliance risks.

  • Drive standardization in system configurations and database interpretations.


Qualifications:

Education:

  • Bachelor's degree in Computer Science, Life Sciences, or a related field.

Experience:

  • 1–2 years of experience in Pharmacovigilance Systems Management, Data Management, or a related field.

Skills:

  • Proficiency in ARGUS or ARISg PV systems and understanding of their architecture.

  • Strong skills in SQL, Excel, Word, PowerPoint, and SharePoint.

  • Familiarity with pharmacovigilance terminology and conventions.

  • Excellent analytical and problem-solving abilities.

  • Effective oral and written communication with strong attention to detail.

  • Ability to work independently, handle multiple priorities, and adapt to shifting deadlines.

  • Working knowledge of ICH guidelines, FDA, and EU PV regulations.


Work Conditions:

  • Flexible hours may be required to support global teams.

  • May involve shift work depending on business requirements.


Additional Information:

  • Baxter provides reasonable accommodations for individuals with disabilities during the hiring process.

  • Be alert to fraudulent job offers. Refer to Baxter’s official Recruitment Fraud Notice for more information.