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Pharmacovigilance It Systems Specialist

10+ years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 IT Systems Specialist – Bangalore | Full-Time

Job Summary

Join a global healthcare innovator as a Pharmacovigilance IT Systems Specialist based in Bangalore, India. In this role, you will lead and manage critical safety database systems, regulatory compliance operations, and digital infrastructure for pharmacovigilance. You’ll play a strategic role in E2B Gateway projects, data integrity, validation (GAMP), and LSMT platform releases. If you’re a pharmacovigilance IT veteran with over 10 years of experience, this is a high-impact opportunity to shape patient safety systems worldwide.


Key Responsibilities:

  • Lead implementation and continuous improvement of PV system solutions

  • Ensure regulatory compliance with ICH, GVP, FDA CFR Part 11, GxP guidelines

  • Support high-priority projects like E2B Gateway exchange and data migration

  • Oversee LSMT platform releases, service operations, and lifecycle management

  • Act as key liaison between system users and global technical teams

  • Ensure software validation using GAMP methodologies

  • Collaborate with global safety, IT, and compliance teams to integrate system enhancements


Required Skills & Qualifications:

  • Bachelor’s or Master’s degree in Life Sciences, IT, or related fields

  • 10+ years of experience in pharmacovigilance database systems

  • Expert in LSMV systems and PV tools (e.g., Argus, ARISg, Oracle/Empirica)

  • Strong regulatory knowledge: ICH-GVP, FDA Part 11, GxP

  • Proficiency in software validation frameworks (GAMP)

  • Experience in service delivery, project and vendor management

  • Excellent communication and stakeholder management skills

  • Fluent in English, both verbal and written


Perks & Benefits:

  • Join a globally recognized healthcare and life sciences leader

  • Inclusive, flexible, and diverse work culture

  • Career development opportunities across continents

  • Competitive compensation and benefits package

  • Work with cutting-edge technology in the drug safety domain


Company Description:

This opportunity is with a global science and technology leader in healthcare, life sciences, and electronics, committed to improving lives through innovation. The organization pioneers advanced pharmacovigilance systems and digital healthcare solutions supporting patients worldwide.


Work Mode: On-site (Bangalore, India)


Call-to-Action:

Are you ready to elevate your impact in pharmacovigilance tech systems? Apply now to become a vital part of a global leader revolutionizing drug safety and patient care.