Job Title: Drug Safety Associate / Pharmacovigilance Officer I
Location: Bangalore, Karnataka, India
Date Posted: 5 September 2025
Category: Pharmacovigilance / Drug Safety
Experience Level: Entry to Mid-level
Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. The company promotes a career environment driven by entrepreneurship, innovation, collaboration, and empathy. Indegene offers accelerated global growth opportunities, mentorship by industry experts, and exposure to the intersection of healthcare and technology.
Website: www.careers.indegene.com
The Drug Safety Associate is responsible for handling individual case safety reports (ICSRs) in compliance with regulatory requirements. The role involves case validation, coding, follow-up, narrative drafting, and supporting pharmacovigilance operations to ensure patient safety.
Confirm validity of cases by identifying minimum criteria for case creation.
Perform duplicate searches and create initial or follow-up cases.
Understand patient safety case-handling principles, including regulatory requirements for reporting 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 safety information, queries, and follow-up details.
Facilitate follow-ups based on queries or inconsistent/missing information in source files.
Perform medical coding (adverse events, medical history, lab data, indications) using MedDRA or other standardized dictionaries.
Code products (suspect/co-suspect, concomitant) according to client conventions and regulatory guidelines.
Draft case narratives.
Must Have:
Understanding of case-handling processes and overall drug research processes.
Cognitive abilities: verbal reasoning, attention to detail, critical and analytical thinking.
Knowledge of therapy area and medical terminology.
Good comprehension skills.
Strong verbal and written communication in English; effective interpersonal skills.
Nice to Have:
Additional experience in pharmacovigilance or related healthcare operations.
Promotes inclusion and diversity.
Equal employment opportunity employer; no discrimination based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or other characteristics.
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