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Sme-Pharmacovigilance

3+ years
Not Disclosed
10 July 8, 2025
Job Description
Job Type: Full Time 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

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.