Job Title:
SME – Pharmacovigilance (Hybrid) – Mumbai, India
Job Summary
Cognizant is hiring an SME – Pharmacovigilance for its growing life sciences division in Mumbai. This hybrid role involves managing ICSR processing using ARGUS, monitoring drug safety from various sources, and supporting regulatory compliance across therapeutic areas like Oncology, CNS, CVS, Immunology, and Gene Therapy. Ideal for pharmacovigilance professionals with at least 3 years of case processing experience, this is a high-impact opportunity to ensure patient safety and product integrity at a global level.
Key Responsibilities
Perform triage and intake of ICSRs in ARGUS within specified timelines
Download and review ICSRs from EudraVigilance and other sources
Process spontaneous, solicited, clinical trial, and literature cases
Conduct MedDRA coding for events, indications, and history
Enter and update case data following SOPs and WIs with accuracy
Amend narratives and assess product labeling relevance
Submit processed cases to health authorities and partners
Collaborate with stakeholders and internal teams
Attend internal/client training to maintain compliance
Participate in SOP development and training support
Resolve technical/process issues proactively
Work rotational shifts across time zones
Required Skills & Qualifications
Bachelor’s or Master’s in Pharmacy
Minimum 3 years of experience in pharmacovigilance case processing
Experience with ARGUS Safety Database
Exposure to therapeutic areas: CVS, CNS, Oncology, Immunology, Gene Therapy
Strong understanding of ICH-GCP, GVP, and global PV regulations
Familiarity with MedDRA coding and PV data entry standards
Proficiency in Microsoft Office tools
Strong communication, analytical, and technical skills
Ability to work in a hybrid and shift-based environment
Perks & Benefits
Competitive salary based on experience
Hybrid work model with rotational shifts
Career growth in a global pharma client environment
Exposure to diverse therapeutic areas
Private healthcare benefits
Learning & development programs
Collaborative and inclusive work culture
Company Description
Cognizant is a global leader in transforming pharmaceutical and healthcare operations through digital innovation and regulatory expertise. With over 300,000 associates worldwide, Cognizant partners with the world’s top life sciences companies to ensure compliance, safety, and clinical excellence. As a Forbes World’s Best Employer 2024, Cognizant fosters a growth-driven and people-first environment.
Work Mode:
Hybrid – Mumbai, India
Call-to-Action
If you're passionate about patient safety and have a solid background in pharmacovigilance, apply now to join Cognizant’s dynamic drug safety team. Shape the future of healthcare with a global leader.
Apply Today!
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