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Pharmacovigilance Submission Specialist

1-4 years
Not Disclosed
10 Nov. 10, 2025
Job Description
Job Type: Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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
Location: Mumbai, India
Employment Type: Full-Time
Experience: 1–4 years
Job ID: 379660
Apply By: 25-Dec-2025

Company Overview:
Tata Consultancy Services (TCS) is hiring for its Pharmacovigilance (Drug Safety) team to support patient safety, case processing, and regulatory submissions to health authorities.

Role Summary:
As a Pharmacovigilance Submission Specialist, you will handle case processing in ARGUS Safety database and assist with global submissions to health authorities, ensuring compliance with regulatory standards and accurate reporting.

Key Responsibilities:

  • Process individual case safety reports (ICSRs) in ARGUS Safety database.

  • Support global submissions of safety data to regulatory health authorities.

  • Ensure compliance with pharmacovigilance procedures, global regulations, and patient safety policies.

  • Maintain accurate documentation for case processing and submissions.

Qualifications:

  • Required: Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm).

  • Alternate Eligible Qualifications: BHMS, BAMS, BDS, MSc (Biotechnology, Zoology).

Desired Skills:

  • Knowledge of pharmacovigilance and drug safety processes.

  • Experience with case processing in ARGUS Safety database.

  • Familiarity with global submission requirements to health authorities.

  • Strong analytical and attention-to-detail skills.

Job Function: Business Process Services
Role Level: Executive