Job Summary
Cognizant is hiring a Subject Matter Expert (SME) in Pharmacovigilance to join its global safety team. The ideal candidate will have a minimum of 3 years of experience in PV case processing and a strong understanding of global safety regulations including ICH, GVP, and GCP. This role demands expertise in ARGUS, MedDRA, and literature-based ICSRs, ensuring high accuracy and compliance with regulatory requirements. Be part of a global pharma leader driving safe and effective drug development.
Key Responsibilities
Perform triage and intake of ICSRs in ARGUS within defined timelines.
Download, validate, and monitor ICSRs from EudraVigilance and other sources.
Process spontaneous, literature, clinical trial, and solicited cases.
Conduct literature searches to identify valid ICSRs.
Generate and submit safety reports to health authorities and partners.
Code medical terms using MedDRA; handle suspect products and narratives.
Perform case follow-up per guidelines and ensure regulatory submissions.
Liaise with internal teams and client stakeholders.
Maintain compliance by attending client/internal trainings.
Contribute to SOP development and training initiatives.
Resolve technical/process issues to streamline operations.
Participate in rotational shifts to support global operations.
Required Skills & Qualifications
Bachelor’s/Master’s degree in Pharmacy.
Minimum 3 years of hands-on case processing experience.
Therapeutic area exposure in CVS, CNS, Oncology, Immunology, and Gene Therapy is a plus.
Familiarity with global pharmacovigilance regulations (ICH, GVP, GCP).
Experience with ARGUS Safety Database and MedDRA coding.
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).
Strong medical terminology knowledge and time management skills.
Perks & Benefits
Opportunity to work with a leading global pharma service provider.
Inclusive, collaborative, and innovation-driven work culture.
Career growth in drug safety, clinical research, and regulatory domains.
Global exposure across multiple therapeutic areas.
Training and skill development programs.
Flexible shift options (rotational).
Company Description
Cognizant is a global leader in digital transformation and professional services, serving top pharma and life sciences clients worldwide. With over 300,000 associates globally, Cognizant empowers healthcare businesses through technology, innovation, and regulatory expertise.
Work Mode: On-site (rotational shifts, global support coverage)
Preferred Experience: 3+ years
Compensation: Not explicitly mentioned; subject to company policy and role expectations
Call-to-Action
Join Cognizant’s global pharmacovigilance team and make an impact in drug safety. Apply today and contribute to patient safety and regulatory excellence across the pharma world.
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