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

Data Officer (India)

PLG groups
1-3 years
Not Disclosed
Remote, India, India
10 May 26, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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, Triage of ICSRs, WHO DD Coding

Job Title

Data Officer (India)

Location

India (Remote work possible)

Employment Type

Permanent Contract

Department

Life Cycle – Safety and Vigilance


Role Overview

The Data Officer is responsible for the accurate processing, management, and regulatory handling of pharmacovigilance (vigilance) data, ensuring compliance with internal systems, client requirements, and global regulatory standards.


Key Responsibilities

1. Data Management & Case Processing

  • Manage vigilance inboxes (generic or client-specific)

  • Register initial safety cases in internal tracking systems

  • Perform duplicate checks in safety databases

  • Conduct case triage and initial data entry

  • Write case narratives and perform MedDRA coding

  • Prepare acknowledgment and follow-up communications

  • Conduct case follow-ups via phone or email

  • Detect and document new vigilance cases

  • Maintain updated tracking tools and client files


2. Regulatory Submissions & Compliance

  • Submit cases to:

    • Regulatory authorities

    • Ethics committees

    • Partners and affiliates

  • Ensure compliance with SDEA (Safety Data Exchange Agreements)

  • Handle administrative processing of vigilance files

  • Notify clients as per contractual and regulatory requirements


3. Database & Reporting Activities

  • Generate safety reports (line listings, summary tabulations)

  • Perform database queries for reporting needs

  • Support safety database reporting and analytics activities


Required Qualifications

Education

  • Bachelor’s or Master’s degree in Pharmacy


Experience

  • 1–3 years in pharmacovigilance or case management


Key Technical Skills

  • Pharmacovigilance case processing and triage

  • Safety database usage

  • MedDRA coding and narrative writing

  • Regulatory reporting experience

  • Case tracking and documentation tools


Soft Skills

  • Strong English communication skills

  • Analytical thinking and attention to detail

  • Ability to structure and manage large datasets

  • Client-oriented mindset

  • Strong coordination and communication abilities

  • High accuracy and compliance focus


Core Function

This role ensures end-to-end pharmacovigilance data integrity, from case intake and coding to regulatory reporting and database maintenance, supporting global drug safety compliance.