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.
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