Specialist – Pharmacovigilance (Patient Safety Operations)
Company: Baxter International
Location: Gurgaon, Haryana, India
Job Category: Patient Safety / Pharmacovigilance
Job Type: Full-Time
Req ID: JR-193249
Posted On: December 03, 2025
Experience Required: 2–4 Years
About Baxter
Baxter International is a global healthcare leader dedicated to improving patient outcomes and advancing lifesaving therapies. Since its founding in 1931, Baxter has remained committed to its mission of saving and sustaining lives. With a strong culture of trust, collaboration, and accountability, Baxter empowers employees to make a meaningful global impact through innovation and operational excellence.
Position Overview
The Specialist – Pharmacovigilance (PV) is a key contributor within the Safety Operations team of Global Patient Safety (GPS). This role is responsible for the end-to-end processing and medical review of Individual Case Safety Reports (ICSRs), ensuring accuracy, compliance, and timely regulatory reporting in accordance with global pharmacovigilance requirements.
This position plays a critical role in patient safety monitoring and post-marketing surveillance activities.
Key Responsibilities
Adverse Event Case Processing
Process adverse event reports from all source types, including full case review and data entry
Assess and document seriousness, expectedness, reporter causality, and case outcomes
Ensure accurate selection of suspect products within the Pharmacovigilance Safety Database
Medical Review & Documentation
Draft high-quality medical narratives summarizing all relevant clinical information
Code medical terms using standardized dictionaries such as MedDRA
Apply clinical judgment to validate the accuracy, consistency, and completeness of case data
Case Follow-Up & Quality Control
Initiate and manage case follow-up activities, including query generation, tracking, and coordination with reporters and local affiliates
Perform quality checks and case clean-up activities to support aggregate safety reporting
Ensure adherence to global and regional pharmacovigilance regulations and internal SOPs
Collaboration & Compliance
Work effectively within a global, cross-functional safety team
Manage multiple priorities while meeting strict regulatory timelines
Required Qualifications & Experience
Education
Degree in Nursing, Pharmacy, Life Sciences, or a related scientific discipline
Experience
2–4 years of relevant experience in:
Pharmacovigilance, patient safety, or regulatory roles within the pharmaceutical or healthcare industry, or
Hospital, clinical, or patient care settings with exposure to adverse event handling
Prior experience with ICSR processing and pharmacovigilance databases is preferred
Key Skills & Competencies
Strong medical and clinical knowledge
Excellent written and verbal communication skills
Ability to work independently under tight deadlines and changing priorities
Strong multitasking and organizational abilities
Working knowledge of global and regional safety regulations (ICH, GVP)
Ability to quickly gain proficiency in pharmacovigilance safety systems
Why Join Baxter
Be part of a mission-driven organization focused on global patient safety
Gain exposure to international pharmacovigilance operations
Work in a collaborative and inclusive environment
Build a long-term career in drug safety and regulatory compliance
Equal Employment Opportunity
Baxter is an Equal Opportunity Employer and provides equal employment opportunities to all qualified applicants without regard to race, religion, gender, age, disability, sexual orientation, gender identity, veteran status, or any other legally protected status.
Reasonable Accommodations
Baxter is committed to providing reasonable accommodations for individuals with disabilities throughout the recruitment process. All accommodation requests are handled confidentially.
Recruitment Fraud Notice
Applicants should be aware of recruitment scams. Baxter does not request payment or personal financial information at any stage of the hiring process.
SEO Keywords for Enhanced Visibility
Pharmacovigilance Specialist Jobs India, Patient Safety Jobs Gurgaon, Baxter Drug Safety Careers, ICSR Processing Jobs, MedDRA Coding Roles, Global Patient Safety Careers, PV Operations Jobs India
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