SME Pharmacovigilance – Cognizant India
Location: India (On-site)
Salary/Compensation: Not specified
Job Summary
Cognizant is seeking an experienced SME Pharmacovigilance Specialist to manage ICSR case processing, ARGUS database entries, MedDRA coding, and regulatory reporting. This role involves ensuring drug safety compliance while supporting pharmacovigilance operations across global therapeutic areas including CVS, CNS, oncology, and immunology.
Key Responsibilities
Perform triage and intake of ICSRs in ARGUS databases within defined timelines.
Download and monitor valid ICSRs from EudraVigilance and other sources.
Process literature, spontaneous, clinical trial, and solicited cases.
Code events, indications, and patient history using MedDRA.
Generate safety reports and submit them to health authorities and business partners.
Draft and amend narratives, code suspect products, and label adverse events.
Conduct follow-ups for additional case information and ensure compliance.
Collaborate with internal teams and client stakeholders on safety data.
Maintain adherence to global regulatory standards (ICH, GCP, GVP).
Contribute to SOP development and training of team members.
Support operational troubleshooting and rotational shifts for global coverage.
Required Skills & Qualifications
Bachelor’s/Master’s degree in Pharmacy.
Minimum 3 years of case processing experience.
Expertise in ICSR management and ARGUS database operations.
Knowledge of CVS, CNS, oncology, immunology therapeutic areas.
Understanding of global, regional, and local regulatory requirements including ICH, GVP, and GCP guidelines.
Strong organizational, time management, and analytical skills.
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).
Strong medical terminology knowledge and attention to detail.
Perks & Benefits
Opportunity to work with a leading global professional services company.
Collaborative and inclusive workplace culture.
Career growth opportunities with international exposure.
Access to cutting-edge pharmacovigilance systems and processes.
Company Description
Cognizant is a global leader in digital and technology services with over 300,000 associates worldwide. Known for innovation and client-centric solutions, Cognizant offers advanced digital transformation and healthcare technology solutions, consistently ranking among Forbes World’s Best Employers.
Work Mode: On-site (India)
Call-to-Action
Looking to advance your career in pharmacovigilance and drug safety? Apply now for the SME Pharmacovigilance role at Cognizant and contribute to global drug safety operations.
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