Job Title: Drug Safety Associate
Date Posted: 5 Sept 2025
Location: Bangalore, KA, India
Company Overview:
Indegene is a technology-led healthcare solutions provider enabling healthcare organizations to be future-ready. The company offers accelerated global growth opportunities for talent that is bold, industrious, and nimble. Employees gain a unique career experience guided by passion, innovation, collaboration, and empathy.
Key highlights:
Exposure to pharmacovigilance and drug safety operations
Mentorship from industry experts
Fast-track global career growth opportunities
Role Purpose:
The Drug Safety Associate (Associate – Pharmacovigilance Officer I) is responsible for supporting patient safety case-handling activities and ensuring compliance with regulatory requirements. This includes validating cases, coding, drafting narratives, and facilitating follow-ups.
Key Responsibilities:
Confirm the validity of cases by identifying minimum criteria for case creation.
Perform duplicate searches to create initial or follow-up cases.
Understand principles and concepts associated with patient safety case-handling processes, including regulatory requirements for reporting Individual Case Safety Reports (ICSRs).
Identify serious adverse events and special scenario cases (e.g., lack of efficacy, exposure, pregnancy, at-risk cases, product quality complaints).
Attach relevant source documents or any safety information/queries/follow-up information.
Facilitate follow-up based on queries from Data Entry, QC, Medical Review, or missing/inconsistent source information.
Code adverse events, medical history, lab data, indications, and products (suspect/co-suspect, concomitant) using standardized terminology (e.g., MedDRA) and client conventions.
Draft narratives for safety cases.
Desired Profile:
Must Have:
Understanding of case-handling principles and overall drug research process.
Cognitive abilities including verbal reasoning, attention to detail, and analytical thinking.
Knowledge of therapy areas and medical terminology.
Good comprehension and understanding of project-specific instructions.
Strong verbal and written communication skills in English and good interpersonal skills.
Nice to Have:
Additional desired qualities relevant to PV operations (optional).
Skills & Competencies:
Attention to detail
Critical thinking and analytical skills
Good comprehension skills
Effective verbal and written communication skills
Equal Opportunity:
Indegene is committed to inclusion and diversity. Employment decisions are based on business requirements, merit, and qualifications.
All qualified applicants will receive consideration without regard to:
Race, color, religion, sex, or national origin
Gender identity or sexual orientation
Disability status or protected veteran status
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