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Drug Safety Associate

Indegene
Indegene
0-2 years
Not Disclosed
10 Sept. 12, 2025
Job Description
Job Type: Full Time 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: Drug Safety Associate / Pharmacovigilance Officer I
Location: Bangalore, Karnataka, India
Date Posted: 5 September 2025
Category: Pharmacovigilance / Drug Safety
Experience Level: Entry to Mid-level


About Indegene

Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. The company promotes a career environment driven by entrepreneurship, innovation, collaboration, and empathy. Indegene offers accelerated global growth opportunities, mentorship by industry experts, and exposure to the intersection of healthcare and technology.

Website: www.careers.indegene.com


Job Overview

The Drug Safety Associate is responsible for handling individual case safety reports (ICSRs) in compliance with regulatory requirements. The role involves case validation, coding, follow-up, narrative drafting, and supporting pharmacovigilance operations to ensure patient safety.


Key Responsibilities

  • Confirm validity of cases by identifying minimum criteria for case creation.

  • Perform duplicate searches and create initial or follow-up cases.

  • Understand patient safety case-handling principles, including regulatory requirements for reporting ICSRs.

  • Identify serious adverse events and special scenario cases (e.g., lack of efficacy, exposure, pregnancy, at-risk cases, product quality complaints).

  • Attach relevant source documents or safety information, queries, and follow-up details.

  • Facilitate follow-ups based on queries or inconsistent/missing information in source files.

  • Perform medical coding (adverse events, medical history, lab data, indications) using MedDRA or other standardized dictionaries.

  • Code products (suspect/co-suspect, concomitant) according to client conventions and regulatory guidelines.

  • Draft case narratives.


Qualifications

Must Have:

  • Understanding of case-handling processes and overall drug research processes.

  • Cognitive abilities: verbal reasoning, attention to detail, critical and analytical thinking.

  • Knowledge of therapy area and medical terminology.

  • Good comprehension skills.

  • Strong verbal and written communication in English; effective interpersonal skills.

Nice to Have:

  • Additional experience in pharmacovigilance or related healthcare operations.


Work Environment and Culture

  • Promotes inclusion and diversity.

  • Equal employment opportunity employer; no discrimination based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or other characteristics.