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Pharmacovigilance Submission Specialist

1-4 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Pharmacovigilance Submission Specialist (TCS) | Mumbai | 1–4 Years Experience

Category: Pharmacovigilance / Drug Safety
Job Type: Full-Time | On-site
Job ID: 379660

Tata Consultancy Services (TCS) is hiring an experienced Pharmacovigilance Submission Specialist to support global drug safety operations. This role requires hands-on expertise in case processing, regulatory submissions, and safety database management.


Position Overview

The Pharmacovigilance Submission Specialist will be responsible for processing adverse event cases, performing regulatory submissions to global health authorities, and ensuring timely, compliant safety reporting. The role demands accuracy, strong analytical skills, and experience with ARGUS or similar PV databases.


Key Responsibilities

  • Perform end-to-end case processing activities, including data entry, coding, narrative preparation, and medical review support.

  • Manage global safety submissions to health authorities in accordance with regulatory timelines and guidelines.

  • Ensure compliance with Pharmacovigilance SOPs, global regulations, and quality standards.

  • Review and validate case data within ARGUS or relevant safety systems.

  • Support the Drug Safety team with accurate and timely submission deliverables.

  • Maintain documentation and submission records as per industry and organizational standards.


Required Experience

  • 1 to 4 years of relevant experience in Pharmacovigilance and drug safety submissions.

  • Experience in case processing using ARGUS Safety Database is essential.

  • Exposure to global regulatory submission workflows preferred.


Educational Qualifications

  • B.Pharm / M.Pharm

  • BAMS / BHMS

  • BDS

  • MSc in Biotechnology or Zoology


Skills & Competencies

  • Strong understanding of Pharmacovigilance guidelines and regulatory reporting requirements.

  • Proficiency in safety databases, especially ARGUS.

  • Good analytical, documentation, and communication skills.

  • Ability to manage timelines and work in a quality-driven environment.


Location

Mumbai, Maharashtra, India


Job Function

Business Process Services
Role: Executive