Baxter Hiring for Pharmacovigilance Safety Operations in Ahmedabad. Process global AE reports, ensure compliance. Apply by 9-Dec-2025.
Job Requisition ID: JR-190289
Location: Ahmedabad, Gujarat, India
Employment Type: Full Time
Application Closing Date: 9 December 2025 (only 7 days left to apply as of 2-Dec-2025)
Department: Global Patient Safety (GPS) – Safety Operations Team
Key Highlights
- Global healthcare leader Baxter – Mission to Save and Sustain Lives since 1931
- Full individual case safety report (ICSR) ownership from intake to regulatory submission
- Hands-on processing of adverse events from clinical trials, post-marketing, literature, and patient programs
- Opportunity to work with worldwide safety regulations (EMA, FDA, PMDA, NMPA, etc.)
- Fast-paced, high-visibility role in one of the most respected pharmacovigilance teams in the industry
- Located in Ahmedabad – one of India’s fastest-growing pharma and clinical research hubs
- Excellent growth path toward Senior Specialist, Case Processing Lead, and GPS leadership roles
Baxter Hiring for Pharmacovigilance Safety Operations
About Baxter and the Global Patient Safety Team
Baxter touches millions of lives every day through critical products in renal care, acute therapies, medication delivery, and surgical solutions. The Global Patient Safety (GPS) organization is the guardian of patient safety across the entire product lifecycle. Baxter Hiring for Pharmacovigilance Safety Operations
As a Specialist, Pharmacovigilance (Safety Operations), you will be a full case owner responsible for end-to-end processing of individual case safety reports (ICSRs) originating from all sources worldwide — spontaneous reports, clinical trials, literature, patient support programs, and solicited sources. Accuracy, speed, and regulatory compliance are non-negotiable because every report you process directly contributes to protecting patients and sustaining Baxter’s license to operate globally. Baxter Hiring for Pharmacovigilance Safety Operations
Core Responsibilities – What You Will Do Every Day
- Perform triage, full data entry, and medical review of incoming adverse event reports from all sources
- Determine seriousness, labeledness (expectedness), causality (reporter and company), and ensure correct suspect product selection in the global safety database (ARGUS preferred)
- Write clear, concise, medically accurate English narratives that stand up to health authority inspection
- Perform accurate MedDRA coding (latest version) and WHO Drug coding
- Apply strong clinical/medical judgment to identify missing or discrepant information
- Generate, track, and follow up on high-quality follow-up queries to reporters, affiliates, and partners
- Meet strict regulatory reporting timelines (15-day for serious unexpected, 48-hour expedited where required)
- Conduct peer quality review of cases processed by team members when required
- Support case clean-up and data reconciliation activities ahead of PSUR/PBRER, DSUR, and signal detection runs
- Contribute to continuous improvement of case-processing SOPs and work instructions
- Maintain 100% compliance with GPS training curriculum and individual performance metrics
Baxter Hiring for Pharmacovigilance Safety Operations
Essential Qualifications and Skills
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Nursing (B.Sc Nursing/GNM), Life Sciences, or equivalent
- Minimum 2–3 years of hands-on individual case safety report processing experience strongly preferred
- Alternatively, 2–3 years of direct patient-care experience (hospital ward, ICU, emergency, dialysis unit, etc.) with strong clinical acumen
- Solid understanding of global pharmacovigilance regulations (ICH E2B R3, GVP Modules, FDA 21 CFR 314.80, EU Volume 9A, etc.)
- Proven MedDRA and WHO Drug coding skills
- Excellent medical writing and narrative-writing abilities in English
- Proficiency with at least one global safety database (ARGUS, ARISg, or Oracle Argus highly desirable)
- Ability to work accurately under strict deadlines in a high-volume environment
- Strong team player with the ability to work independently with minimal supervision
- Excellent oral and written English communication
Baxter Hiring for Pharmacovigilance Safety Operations
Preferred Experience (Will Give You a Strong Edge)
- Prior experience in Baxter, Fresenius, B.Braun, Terumo, or other large medical device/pharma companies
- End-to-end ICSR processing experience including E2B submission
- Experience with literature review and medical device vigilance (MDR/IVDR)
- Familiarity with signal detection support or aggregate report preparation
- Certification in pharmacovigilance (e.g., PGDip, Uppsala Monitoring Centre courses)
Life at Baxter Ahmedabad
The Ahmedabad Global Capability Center is a strategic hub for pharmacovigilance, regulatory affairs, and clinical operations. You will enjoy: Baxter Hiring for Pharmacovigilance Safety Operations
- Modern office with excellent connectivity
- Comprehensive benefits including health insurance for self + family, transport allowance, and annual bonus
- Structured career progression framework within Global Patient Safety
- Ongoing training on the latest regulatory guidelines and safety database upgrades
- A culture that genuinely lives its values: courage, collaboration, and accountability
How to Apply – Step-by-Step (Do This Today)
Applications are accepted only through the official Baxter Careers portal. Third-party or email applications will not be considered. Baxter Hiring for Pharmacovigilance Safety Operations
- Go to the official job posting: https://jobs.baxter.com/job/JR-190289
(Or search requisition number JR-190289 on https://jobs.baxter.com) - Click the “Apply Now” button
- Log in or create your Baxter candidate profile
- Upload your latest CV (Word or PDF format, max 2 MB)
- Complete all mandatory fields and the short questionnaire
- Submit your application before 23:59 IST on 9 December 2025
Note: This position is moving fast — high-quality applications received early may trigger closure before the official deadline. Baxter Hiring for Pharmacovigilance Safety Operations
Final Message from Baxter
This is more than a job — it is a calling. Every case you process, every narrative you write, every timeline you meet has the power to protect a patient somewhere in the world. If you are detail-oriented, clinically sharp, and passionate about pharmacovigilance, bring your talent to Baxter and help us continue Saving and Sustaining Lives for the next 90 years and beyond.
Apply today and take the next step in your global pharmacovigilance career. Baxter Hiring for Pharmacovigilance Safety Operations
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