SME – Pharmacovigilance (Case Processing Expert)
Location: India (Exact location not specified)
Work Mode: Rotational Shifts (On-site/Hybrid based on client need)
Experience: Minimum 3 years
Industry: Pharmacovigilance, Drug Safety, Clinical Research
Job Summary:
Cognizant is hiring a Subject Matter Expert – Pharmacovigilance to lead and optimize end-to-end case processing activities. This role is ideal for experienced professionals with strong knowledge of ARGUS, MedDRA, and GVP compliance. You will play a key role in drug safety, regulatory submissions, and training support within a global PV framework.
Key Responsibilities:
Perform triage, intake, and entry of ICSRs into ARGUS safety database within defined timelines
Monitor and process cases from EudraVigilance, literature, clinical trials, and solicited sources
Conduct MedDRA coding for events, indications, and patient history
Amend narratives and label events according to regulatory standards
Generate reports and submit to health authorities and partners
Communicate proactively with internal teams and client stakeholders
Ensure regulatory and SOP compliance across all pharmacovigilance activities
Develop and refine SOPs for case processing and quality consistency
Provide support and training to new team members and ensure upskilling
Troubleshoot and resolve process issues, ensuring uninterrupted workflow
Work in rotational shifts to support global operations across time zones
Required Skills & Qualifications:
Bachelor’s or Master’s in Pharmacy
Minimum 3 years of PV case processing experience
Therapeutic area expertise in Cardiovascular, CNS, Oncology, Immunology, Gene Therapy preferred
Strong working knowledge of GVP, ICH-GCP, and global regulatory requirements
Proficient in ARGUS, MedDRA, Microsoft Office tools
Good knowledge of medical terminology and PV workflow
Experience with a global pharma sponsor preferred
Strong time management, communication, and organizational skills
Perks & Benefits:
Opportunity to work with a globally recognized pharma client
Inclusion in a collaborative and high-caliber pharmacovigilance team
Continuous learning through client and internal training programs
Career development pathways within one of the Forbes World’s Best Employers 2024
Exposure to cutting-edge PV technologies and global regulations
Company Description:
Cognizant is a global leader in IT and professional services, offering advanced digital, data, and consulting solutions across healthcare and life sciences. With over 300,000 associates worldwide, Cognizant is consistently recognized among the most admired and innovative employers globally.
Work Mode: Rotational Shifts (On-site or Hybrid based on project)
Compensation: Not specified (competitive and subject to location and experience)
Call to Action:
Advance your PV career with a global leader. If you’re an experienced case processing expert ready to make an impact in drug safety, apply now to join Cognizant’s pharmacovigilance team.
Submit your application today and help safeguard patient safety worldwide.
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