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Sme-Pharmacovigilance

3+ years
Not Disclosed
10 June 27, 2025
Job Description
Job Type: Hybrid 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

 

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!