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Spec, Pv

Baxter
Baxter
2-3 years
Not Disclosed
10 Dec. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Pharmacovigilance Specialist (Patient Safety) – Gurgaon, India

Category: Patient Safety
Location: Gurgaon, Haryana, India
Job ID: JR-193249
Posted on: December 3, 2025

About the Role

Baxter is dedicated to redefining healthcare delivery and improving patient lives worldwide. As a Pharmacovigilance (PV) Specialist within the Global Patient Safety (GPS) Safety Operations team, you will play a critical role in ensuring the safety, accuracy, and compliance of individual case safety reports. This position is ideal for professionals who want to make a meaningful impact in global patient safety and regulatory operations.

Key Responsibilities

  • Perform end-to-end processing of adverse event reports from all sources, including complete data entry, assessment of seriousness, expectedness, causality, and event outcomes.

  • Ensure accurate identification and selection of the suspect drug in the Pharmacovigilance Safety System.

  • Write clear, medically accurate narratives summarizing relevant clinical information for individual case safety reports.

  • Code medical terms using standardized medical dictionaries such as MedDRA.

  • Apply medical judgment to ensure all data is complete, accurate, and correctly coded in the safety database.

  • Request follow-up information and coordinate case investigations with global teams and local affiliates.

  • Conduct quality checks when required and support case clean-up activities for aggregate safety reporting.

  • Collaborate effectively within a global team to meet regulatory timelines and internal quality standards.

Required Qualifications and Skills

  • Strong medical and clinical knowledge.

  • Excellent written and verbal communication skills.

  • Ability to work independently under strict timelines and shifting priorities.

  • Strong attention to detail and ability to multitask in a fast-paced environment.

  • Effective teamwork and collaboration capabilities.

  • Working knowledge of global and regional pharmacovigilance regulations.

  • Ability to gain proficiency in Pharmacovigilance Safety Systems.

Education & Experience Requirements

  • Degree in Nursing, Pharmacy, Life Sciences, or an equivalent clinical qualification.

  • Experience in the pharmaceutical industry, preferably within Regulatory or Safety functions, is an advantage.

  • 2–3 years of hospital, patient care, or equivalent clinical experience preferred.

Equal Opportunity Statement

Baxter is an equal opportunity employer. All qualified applicants will be considered without discrimination based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other protected characteristic.

Accessibility & Accommodations

Baxter is committed to supporting individuals with disabilities throughout the hiring process. Candidates requiring a reasonable accommodation due to a medical condition or disability may request assistance during any stage of the application or interview process.

Recruitment Fraud Awareness

Applicants are advised to stay alert to fraudulent job communications. Baxter does not request personal or financial information outside of the official hiring process. Learn more through the company’s Recruitment Fraud Notice.