Job Title: SPE – Pharmacovigilance (Junior Data Analyst)
Company: Cognizant
Job ID: 00069182951
Job Category: Technology & Engineering
Work Mode: Hybrid
Location: Mumbai, India
Posted Date: 17 June 2026
Job Summary
The SPE – Pharmacovigilance is responsible for processing Individual Case Safety Reports (ICSRs), ensuring regulatory compliance, managing pharmacovigilance activities, maintaining safety databases, and supporting global drug safety operations while adhering to international pharmacovigilance guidelines.
Key Responsibilities
Perform triage and intake of Individual Case Safety Reports (ICSRs) in the ARGUS database within defined timelines.
Download and monitor valid ICSRs from EudraVigilance (EV) and other reporting sources.
Process literature, spontaneous, clinical trial, and solicited adverse event cases.
Search and identify valid ICSRs using literature search tools.
Generate safety reports and submit them to health authorities and business partners.
Enter serious and non-serious ICSRs into the ARGUS database with high accuracy.
Code adverse events, indications, and medical history using MedDRA.
Code suspect products, update narratives, and label events appropriately.
Obtain follow-up information for incomplete or pending safety cases.
Submit processed cases to regulatory authorities as per applicable guidelines.
Communicate effectively with clients, stakeholders, and internal teams.
Participate in internal and client training programs.
Ensure compliance with GCP, GVP, ICH guidelines, SOPs, and regulatory requirements.
Support SOP development and continuous process improvement initiatives.
Troubleshoot process-related issues and maintain smooth workflow.
Work in rotational shifts to support global pharmacovigilance operations.
Required Qualifications
Bachelor's or Master's Degree in Pharmacy (B.Pharm / M.Pharm).
Minimum 1 year of relevant Pharmacovigilance case processing experience.
Good understanding of pharmacovigilance regulations and safety reporting.
Experience with ARGUS Safety Database.
Knowledge of MedDRA coding.
Good communication and documentation skills.
Preferred Experience
Experience in global pharmaceutical companies.
Experience in therapeutic areas such as:
Cardiovascular (CVS)
Neuroscience (CNS)
Oncology
Immunology
Gene Therapy
Knowledge of:
Good Clinical Practice (GCP)
Good Pharmacovigilance Practice (GVP)
ICH Guidelines
Experience with EudraVigilance (EV).
Required Skills
Pharmacovigilance
ICSR Case Processing
ARGUS Safety Database
MedDRA Coding
EudraVigilance (EV)
Literature Screening
Adverse Event Reporting
Regulatory Compliance
GCP
GVP
ICH Guidelines
Medical Terminology
Microsoft Excel
Microsoft Word
PowerPoint
Documentation
Attention to Detail
Time Management
Communication Skills
Experience
1–4 years of Pharmacovigilance experience with expertise in ICSR case processing, ARGUS database, MedDRA coding, and global safety reporting.
Estimated Salary Package (Market Standard)
Fixed CTC: ₹4.5 LPA – ₹8.5 LPA
Performance Bonus: ₹30,000 – ₹1 LPA
Total Expected Package: ₹5 LPA – ₹9.5 LPA (depending on experience, current CTC, and interview performance)
Why Join Cognizant
Work with a leading global technology and life sciences organization.
Exposure to global pharmacovigilance and drug safety projects.
Hybrid working model with international client interaction.
Career growth in regulatory affairs and drug safety operations.
Structured learning, training, and professional development opportunities.
Application Status
Posted On: 17 June 2026
Job Type: Full-time
Work Location: Mumbai (Hybrid)
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