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Spec, Pv

2-3 years
Not Disclosed
10 Oct. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Specialist, Pharmacovigilance (PV)

Req ID: JR-188653
Location: Ahmedabad, Gujarat, India
Department: Patient Safety
Date Posted: October 27, 2025
Company: Baxter


About Baxter

At Baxter, we believe that every person—regardless of who they are or where they are from—deserves the opportunity to live a healthy life. Since our founding in 1931, this principle has guided us in redefining healthcare delivery to make a meaningful impact—today, tomorrow, and beyond.

Our colleagues are united by our Mission: “To Save and Sustain Lives.”
We value courage, trust, and collaboration, empowering every individual to make a difference. At Baxter, you will find not just a job—but purpose and pride.


Position Overview

This role is part of the Safety Operations team within Global Patient Safety (GPS).
The Pharmacovigilance Specialist will be responsible for the end-to-end processing of Individual Case Safety Reports (ICSRs), including accurate data entry, medical review, narrative writing, and compliance with global safety reporting timelines.


Key Responsibilities

  • Process adverse event reports from all source types.

  • Review and perform full data entry for ICSRs, assessing:

    • Seriousness and expectedness

    • Reporter’s causality

    • Event outcome/resolution

  • Ensure correct selection of suspect drug/product within the PV Safety System.

  • Write medical narratives summarizing all relevant information for each case.

  • Code medical terms using standardized dictionaries (e.g., MedDRA).

  • Use medical and clinical judgment to confirm data accuracy and completeness.

  • Conduct case investigations by generating and tracking queries and following up with reporters/local affiliates.

  • Perform quality control (QC) checks and case cleanup as required.

  • Support aggregate report preparation activities when needed.


Qualifications

  • Strong medical and clinical knowledge.

  • Excellent oral and written communication skills.

  • Effective team player with the ability to work independently under deadlines.

  • Strong organizational and multitasking abilities.

  • Working knowledge of global and regional safety regulations.

  • Proficiency in Pharmacovigilance Safety Systems.


Education & Experience

  • Degree: Nursing, Pharmacy, Life Sciences, or equivalent.

  • Preferred Experience:

    • 2–3 years in hospital/patient care or equivalent clinical environment.

    • Prior experience in pharmaceutical industry (Regulatory or Safety) preferred.


Equal Employment Opportunity

Baxter is an Equal Opportunity Employer.
All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity/expression, veteran status, or disability.


Reasonable Accommodations

Baxter is committed to providing reasonable accommodations for individuals with disabilities.
If you require an accommodation during the application or interview process, please contact us via the provided link with your request and contact information.


Recruitment Fraud Notice

Beware of fraudulent recruitment activities impersonating Baxter representatives.
To learn how to protect yourself, please review our official Recruitment Fraud Notice on the Baxter Careers website.


Application

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