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Drug Safety Associate

0-2 years
Not Disclosed
10 Sept. 22, 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 (Associate – Pharmacovigilance Officer I)

Company: Indegene
Location: Pune, MH, India
Date Posted: 20 Sept 2025


Company Overview

Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. The company emphasizes accelerated global growth opportunities, entrepreneurship, mentorship, and operates at the intersection of healthcare and technology.


Role Overview

The Drug Safety Associate is responsible for handling individual case safety reports (ICSRs), performing case coding, ensuring regulatory compliance, and supporting pharmacovigilance activities to optimize patient safety.


Key Responsibilities

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

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

  • Understand patient safety case-handling principles and regulatory requirements for ICSRs.

  • Identify serious adverse events and special scenario cases, including:

    • Lack of efficacy

    • Exposure and pregnancy cases

    • At-risk cases

    • Product quality complaint-only cases

  • Attach relevant source documents, safety information, or follow-up information to cases.

  • Facilitate follow-up queries from Data Entry, QC, Medical Reviewers, or based on inconsistent/missing source data.

  • Perform coding for:

    • Adverse events

    • Medical history

    • Lab data

    • Indications
      Using standardized medical terminology dictionaries such as MedDRA.

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

  • Draft narratives for individual cases.


Required Qualifications & Skills

  • Education: Life Sciences/Medical/Pharmacy degree (M.Pharm/Pharm D)

  • Understanding of case-handling principles and the overall drug research process.

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

  • Good knowledge of therapy areas and medical terminology.

  • Strong comprehension, verbal, and written communication skills in English.

  • Interpersonal skills for effective teamwork and collaboration.


Preferred / Nice-to-Have Skills

  • Prior experience in pharmacovigilance or medical safety operations.


Equal Opportunity Statement

Indegene is committed to inclusion and diversity and does not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other protected characteristic. Employment decisions are based on business requirements, candidate merit, and qualifications.