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Safety Systems Analyst Ii

4+ years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: BCS/B.Tech/B.E. 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 II
Location: Bengaluru, Karnataka, India
Department: GST Operations
Employment Type: Full Time


Company Overview:

At Baxter, your work makes a global impact by saving and sustaining lives. With over 85 years of innovation, Baxter’s therapies and technologies are present in almost every hospital and many homes around the world. Here, you’ll find purpose, connection, and the opportunity to do your best work.


Position Summary:

The Safety Systems Analyst II is a senior role within the Global Patient Safety (GPS) – Technology team. This role focuses on managing pharmacovigilance (PV) systems and databases, supporting data consistency, analysis, reporting, and tracking. This position will also mentor Analyst I team members and be involved in system upgrades and specialized projects.


Key Responsibilities:

System & Data Support:

  • Support and maintain pharmacovigilance safety systems (e.g., ARGUS, ARISg).

  • Collaborate with IT and vendors for implementing system changes.

  • Review user requirements and assist with validation processes.

  • Configure and manage PV system databases and reporting templates.

  • Create, customize, and automate database queries and reporting activities.

  • Track and manage system changes via SharePoint.

Oversight & Training:

  • Lead daily activities of Analyst I team members.

  • Deliver training on system configurations and administration.

  • Provide support for PV database upgrades and validation.

  • Drive alignment of system conventions, standards, and business rules.

Change Management & Compliance:

  • Monitor change control processes for database updates.

  • Review and maintain safety data elements such as user access, product dictionaries, and SDEAs.

  • Ensure regulatory compliance (FDA, EU, ICH).


Qualifications:

Education:

  • Bachelor’s degree or higher in Computer Science, Life Sciences, or related fields.

Experience:

  • 4+ years in PV Systems Management, Data Management, or equivalent.

  • Experience with ARGUS, ARISg, or similar pharmacovigilance systems.

  • Proven experience in system configurations, data management, and report generation.

Skills:

  • Proficiency in SQL, Excel, Word, PowerPoint, SharePoint.

  • Strong technical, analytical, and problem-solving capabilities.

  • Deep understanding of pharmacovigilance terminology and system architecture.

  • Excellent communication and interpersonal skills.

  • Ability to multitask and meet tight deadlines in a global team environment.


Work Conditions:

  • Standard 40-hour workweek (Monday–Friday) with flexibility to support global time zones.

  • May require shift work depending on project needs.


Additional Information:

  • Baxter is an equal opportunity employer and provides reasonable accommodations to applicants with disabilities.

  • Be aware of recruitment scams posing as Baxter representatives. For more details, refer to Baxter’s official Recruitment Fraud Notice.