Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Pharmacovigilance Submission Specialist

1-4 years
Not Disclosed
10 Nov. 6, 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

Company: TCS
Role: Pharmacovigilance – Submission Specialist
Work Location: Mumbai
Experience: 1–4 years of relevant experience in Pharmacovigilance
Job Function: Business Process Services
Role Level: Executive
Job ID: 379660


About the Role

TCS is hiring experienced Pharmacovigilance Submission Specialists to join our Drug Safety team. The ideal candidate will have hands-on experience in case processing and global submissions to health authorities using ARGUS and will contribute to ensuring regulatory compliance and high-quality deliverables.


Key Responsibilities

  • Perform case processing activities in the ARGUS safety database, ensuring accuracy and compliance with global pharmacovigilance regulations.

  • Manage and execute global safety submissions to Health Authorities within required timelines.

  • Ensure the quality, accuracy, and consistency of individual case safety reports (ICSRs).

  • Collaborate with internal teams to ensure timely resolution of queries and completion of case processing workflows.

  • Maintain compliance with company standard operating procedures (SOPs) and global regulatory requirements.

  • Support audits and inspections related to pharmacovigilance operations and submissions.


Desired Candidate Profile

Qualifications:

  • Mandatory: B.Pharm / M.Pharm

  • Eligible: BAMS / BHMS / BDS / M.Sc (Biotechnology, Zoology)

Skills & Experience:

  • 1–4 years of relevant experience in Pharmacovigilance, specifically in case processing and global submissions.

  • Proficiency in ARGUS Safety Database.

  • Strong understanding of pharmacovigilance principles, regulatory requirements, and submission workflows.

  • Excellent attention to detail, communication, and documentation skills.