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Pharmacovigilance Specialist, Submissions – Remote Pharmacovigilance Jobs In India | Propharma Careers

Propharma
Propharma
1-3 years
Not Disclosed
India
1 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Pharmacovigilance Specialist, Submissions – Remote Pharmacovigilance Jobs in India | ProPharma Careers

Company: ProPharma
Job Title: Pharmacovigilance Specialist, Submissions
Location: India
Job Type: Full-Time
Industry: Pharmacovigilance, Drug Safety, Regulatory Submissions, Clinical Research
Job ID: JR 8766


About ProPharma

ProPharma is a globally recognized life sciences consulting organization that supports biotechnology, pharmaceutical, and medical device companies throughout the product lifecycle. For over 20 years, the company has delivered expertise across regulatory sciences, pharmacovigilance, clinical research, quality compliance, medical information, and R&D technology solutions.

ProPharma partners with healthcare innovators to accelerate drug development, maintain regulatory compliance, and improve patient safety worldwide.


Job Overview

ProPharma is hiring a Pharmacovigilance Specialist, Submissions to support global pharmacovigilance operations and regulatory submission activities.

The role focuses on:

  • Adverse Event Submission Compliance
  • ICSR Submission Management
  • Safety Partner Exchange
  • Periodic Safety Reporting
  • Argus Database Operations
  • Pharmacovigilance Regulatory Compliance

This opportunity is suitable for professionals interested in pharmacovigilance submissions, drug safety reporting, and regulatory operations within a global CRO environment.


Experience Required

Required Experience

  • Prior experience in:
    • Pharmacovigilance
    • Drug Safety
    • Regulatory Submissions
    • ICSR Management
    • Safety Reporting

Preferred Experience

  • Experience in a similar pharmacovigilance submissions role is highly preferred
  • Experience working with:
    • Argus Safety Database
    • E2B Submissions
    • Safety Reporting Compliance
    • Health Authority Submissions

Freshers Eligibility

  • Freshers may apply if they possess relevant pharmacovigilance knowledge and strong technical skills
  • Candidates with prior PV or safety operations experience will be preferred

Educational Qualification

Candidates should possess:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Healthcare-related field

OR

  • Equivalent professional work experience in pharmacovigilance or regulatory safety operations

Key Responsibilities

Adverse Event Submission Management

  • Monitor scheduled expedited and non-expedited ICSR submissions
  • Maintain adverse event submission compliance with:
    • Health Authorities
    • Ethics Committees
    • Institutional Review Boards
    • Safety Partners

ICSR & Safety Exchange Activities

  • Perform monthly ICSR reconciliation activities
  • Support safety partner data exchange operations
  • Assist in gateway-to-gateway submission testing

Periodic Safety Reporting

  • Generate line listings and summary tabulations for periodic safety reports
  • Support setup and verification of reporting requirements
  • Assist with custom periodic reporting activities

Argus Safety Database Activities

  • Work within the multi-tenant Argus database environment
  • Support:
    • Data migration testing
    • System upgrades
    • Patch validation
    • Performance qualification (PQ) testing

Regulatory Compliance & Documentation

  • Assist in deviation management and CAPA activities
  • Update documentation for E2B profiles and territory-specific submission requirements
  • Ensure compliance with pharmacovigilance reporting standards