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Sr. Specialist – Pharmacovigilance (Pv)

2 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.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:

Sr. Specialist – Pharmacovigilance (PV)
Req #: JR - 182806
Location: Gurgaon, Haryana, India
Job Category: Patient Safety
Date Posted: September 5, 2025


🌍 About Baxter

At Baxter, we are united by our mission to Save and Sustain Lives. For over 85 years, our innovations have supported better patient outcomes across hospitals, clinics, and homes. Every employee at Baxter plays a meaningful role in transforming healthcare delivery worldwide.

This is not just a job—it’s a place to do your best work with purpose and pride.


🧭 Position Overview

As a Sr. Specialist in Pharmacovigilance (PV) within the Global Patient Safety (GPS) team, you will be responsible for processing and quality control of adverse event reports. You will serve as a subject matter expert in individual case safety report (ICSR) processing, data entry, coding, and regulatory compliance, ensuring safety reports meet internal standards and regulatory expectations.


🎯 Key Responsibilities

📋 Adverse Event Case Management

  • Process adverse event (AE) reports from various sources (literature and non-literature).

  • Review and enter AE data into the Global Safety Database, ensuring:

    • Accurate assessment of seriousness, expectedness, and causality.

    • Proper suspect drug selection in the Pharmacovigilance Safety System.

  • Write narratives summarizing relevant medical information.

  • Code medical terms using MedDRA and ensure consistency across cases.

🩺 Medical & Quality Oversight

  • Use medical expertise to validate AE data entry and MedDRA coding.

  • Perform quality checks (in-line and retrospective) and case clean-up where needed.

  • Support compliance monitoring, including CAPA (Corrective & Preventive Actions) and quality control metrics.

📚 Training & Collaboration

  • Request case investigations and follow up with reporters alongside local affiliates.

  • Support reconciliation activities across departments and external partners.

  • Train and mentor new team members and contribute to continuous improvement efforts.

  • Contribute to aggregate reporting preparation as needed.

📌 Additional Duties

  • Engage in cross-functional initiatives and process improvements.

  • Participate in other GPS activities and tasks as assigned.


Qualifications & Skills

  • Education: Degree in Pharmacy, Life Sciences, Medicine, or a related health discipline.

  • Experience: Prior experience in pharmacovigilance, case processing, or medical review is preferred.

  • Skills Required:

    • Knowledge of MedDRA coding and pharmacovigilance safety databases.

    • Strong written and verbal communication skills.

    • Detail-oriented with strong analytical and medical interpretation capabilities.

    • Ability to train and guide others.

    • Familiarity with global PV regulations is a plus.


📍 Work Location

Baxter (India) Pvt. Ltd
5th Floor, Tower A, Building No.9
DLF Cyber City, DLF Phase III
Gurgaon – 122002, Haryana, India


⚖️ Equal Employment Opportunity

Baxter is an equal opportunity employer. We do not discriminate based on race, gender, age, religion, sexual orientation, veteran status, disability, or other protected categories.


Reasonable Accommodations

Baxter provides reasonable accommodations for individuals with disabilities throughout the recruitment and interview process.
🔗 Click here to request an accommodation


⚠️ Recruitment Fraud Alert

Be cautious of fraudulent job offers posing as Baxter recruiters. Baxter never requests sensitive personal or financial information during the hiring process.
🔗 Read our Recruitment Fraud Notice


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