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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: Bangalore, KA, India
Date Posted: 17 Sept 2025


Company Overview

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


Role Overview

The Drug Safety Associate will work within the Safety/Pharmacovigilance team, handling individual case safety reports (ICSRs), performing coding, and ensuring compliance with regulatory requirements. The role involves identifying, documenting, coding, and following up on adverse events and other safety-related information.


Key Responsibilities

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

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

  • Understand patient safety case-handling principles, regulatory requirements, and concepts.

  • 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, and follow-up details to cases.

  • Facilitate follow-up queries from data entry, QC, medical reviewers, or source documentation inconsistencies.

  • 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: Medical, M.Pharm, Pharm.D, or Life Sciences degree.

  • Understand principles and concepts of case-handling and drug research processes.

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

  • Good knowledge of therapy areas and medical terminology.

  • Strong comprehension and communication skills (verbal and written) in English.

  • Good interpersonal skills.


Preferred / Nice-to-Have Skills

  • Prior experience in pharmacovigilance, medical coding, or drug 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. All employment decisions are based on business requirements, merit, and qualifications.