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Pharmacovigilance Submission Specialist

Tcs
TCS
1-4 years
Not Disclosed
10 Nov. 11, 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

job Title: Pharmacovigilance – Submission Specialist

Company: Tata Consultancy Services (TCS)
Location: Mumbai
Job ID: 379660
Job Function: Business Process Services
Role: Executive
Experience Required: 1 – 4 years (Relevant experience in Pharmacovigilance)


Qualification Required:

  • B.Pharm / M.Pharm

  • BHMS / BAMS / BDS

  • M.Sc (Biotechnology / Zoology)


Key Responsibilities:

  • Perform case processing activities for ICSRs as per regulatory guidelines.

  • Work on ARGUS Safety Database for case entry, narrative writing, coding, and quality review.

  • Ensure accurate and timely global submissions to respective Health Authorities.

  • Maintain compliance with international pharmacovigilance regulations and company SOPs.

  • Coordinate with cross-functional teams for case follow-ups and data clarification.


Desired Skills:

  • Hands-on experience in Pharmacovigilance case processing

  • ARGUS database working knowledge is mandatory

  • Knowledge of global regulatory reporting requirements

  • Strong communication and documentation skills