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Drug Safety Associate

0-2 years
Not Disclosed
10 Sept. 25, 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

Drug Safety Associate

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


Company Overview

Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready.

  • Provides accelerated global growth opportunities for bold and industrious talent.

  • Work at the convergence of healthcare and technology.

  • Mentorship from industry experts and a fast-track career growth environment.

  • Purpose-driven organization with customer-centric approach.

Learn more: www.careers.indegene.com


Role Overview

The Drug Safety Associate (also referred to as Associate – Pharmacovigilance Officer I) is responsible for supporting patient safety case management and ensuring compliance with pharmacovigilance regulations. The role involves case validation, coding, follow-ups, and narrative drafting.


Key Responsibilities

Case Management

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

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

  • Identify serious adverse events (SAEs) and special scenario cases:

    • Lack of efficacy

    • Exposure and pregnancy

    • At-risk cases

    • Product quality complaint-only cases

  • Attach relevant source documents and safety information.

  • Facilitate follow-up for queries from Data Entry, QC, or Medical Review teams, or for inconsistent/missing data.

Coding & Documentation

  • Code adverse events, medical history, lab data, indications, using standardized medical dictionaries (e.g., MedDRA).

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

  • Draft case narratives for reporting and review.


Requirements

Must-Have

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

  • Cognitive skills: verbal reasoning, attention to detail, analytical thinking.

  • Knowledge of therapy areas and medical terminology.

  • Strong comprehension and verbal/written English communication.

  • Interpersonal skills to collaborate effectively with internal teams.

Nice-to-Have

  • Additional experience or certification in pharmacovigilance or quality processes.


Skills & Competencies

  • Attention to detail and critical thinking.

  • Strong analytical and comprehension skills.

  • Ability to work in a structured and regulated environment.

  • Familiarity with pharmacovigilance case-handling systems and coding practices.


Equal Opportunity Statement

Indegene is an Equal Employment Employer committed to inclusion and diversity. Employment decisions are based on business requirements, merit, and qualifications without regard to:

  • Race, color, religion, sex, age, national origin

  • Pregnancy, sexual orientation, gender identity

  • Physical ability, disability, or protected veteran status

All qualified applicants will receive consideration without discrimination.