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Drug Safety Associate

2+ years
not specified
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: Understanding of drug safety processes and pharmacovigilance regulations Knowledge of the overall drug development and research process Strong attention to detail and cognitive skills (e.g., verbal 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

Date Posted: 5 September 2025
Location: Bangalore, Karnataka, India
Company: Indegene


About Indegene:

Indegene is a technology-led healthcare solutions provider with a mission to make healthcare organizations future-ready. Our culture thrives on passion, innovation, collaboration, and empathy. We offer bold, industrious, and nimble talent the chance to accelerate their careers on a global scale.

At Indegene, you will:

  • Work at the intersection of healthcare and technology

  • Be mentored by experienced industry professionals

  • Embark on a fast-track, high-growth career journey

  • Experience a differentiated work environment focused on purpose and innovation

For more information, visit: www.careers.indegene.com


Position Overview:

As a Drug Safety Associate (Pharmacovigilance Officer I), you will be involved in the end-to-end safety case-handling process. This includes validating, processing, and coding safety information, as well as preparing narrative summaries in compliance with regulatory and client requirements.


Key Responsibilities:

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

  • Conduct duplicate checks to determine whether a case is initial or follow-up

  • Understand and apply regulatory requirements for reporting individual case safety reports (ICSRs)

  • Identify serious adverse events (SAEs) and special scenarios such as:

    • Lack of efficacy

    • Exposure during pregnancy

    • At-risk cases

    • Product quality complaint-only cases

  • Attach relevant source documents and follow-up communications to case files

  • Facilitate follow-ups based on:

    • Queries from Data Entry, Quality Control, or Medical Review teams

    • Inconsistencies or missing data in the source documents

  • Perform medical coding using standardized dictionaries (e.g., MedDRA) for:

    • Adverse events

    • Medical history

    • Lab data

    • Indications

  • Code suspect, co-suspect, and concomitant products as per client and regulatory conventions

  • Draft clear, concise, and medically accurate case narratives


Qualifications & Requirements:

Must-Have:

  • Understanding of drug safety processes and pharmacovigilance regulations

  • Knowledge of the overall drug development and research process

  • Strong attention to detail and cognitive skills (e.g., verbal reasoning, critical and analytical thinking)

  • Proficiency in medical terminology and therapeutic areas

  • Good comprehension skills

  • Strong written and verbal communication skills in English

  • Ability to work collaboratively in a fast-paced, team-oriented environment

Nice-to-Have:

  • Familiarity with safety databases and tools

  • Prior experience in pharmacovigilance or healthcare-related domains


Equal Opportunity Statement:

Indegene is an Equal Opportunity Employer committed to a diverse and inclusive workplace.
We do not discriminate on the basis of:

  • Race, religion, color, age, gender, sexual orientation, national origin, disability, pregnancy, gender identity, veteran status, or any other legally protected status.

All employment decisions are based on business needs, qualifications, and merit.