Job Title: Junior Drug Safety Associate (Associate – Pharmacovigilance Officer I)
Company: Indegene
Location: Bangalore, KA, India
Date Posted: 2 Sept 2025
Company Overview
Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. The company emphasizes accelerated global growth, mentorship, entrepreneurship, and operates at the intersection of healthcare and technology.
Role Overview
The Junior Drug Safety Associate is responsible for supporting pharmacovigilance operations, including handling individual case safety reports (ICSRs), performing coding, ensuring regulatory compliance, and assisting in the preparation of narratives to optimize patient safety.
Key Responsibilities
Confirm validity of safety cases by identifying minimum criteria for case creation.
Perform duplicate searches to create either initial or follow-up cases.
Understand principles and concepts of patient safety case-handling processes, including regulatory requirements for reporting ICSRs.
Identify serious adverse events and special scenario cases:
Lack of efficacy
Exposure and pregnancy cases
At-risk cases
Product quality complaint-only cases
Attach relevant source documents, safety information, or follow-up information to cases.
Facilitate follow-up based on queries from Data Entry, QC, Medical Reviewers, or inconsistent/missing source information.
Perform coding for:
Adverse events
Medical history
Lab data
Indications
Using standardized medical terminology dictionaries such as MedDRA.
Code products (suspect/co-suspect, concomitant) according to client conventions and regulatory requirements.
Draft narratives for individual cases.
Required Qualifications & Skills
Education: Life Sciences/Medical/Pharmacy degree (M.Pharm/Pharm D) or equivalent.
Knowledge of case-handling principles and overall drug research process.
Cognitive abilities: verbal reasoning, attention to detail, critical and analytical thinking.
Knowledge of therapy areas and medical terminology.
Strong comprehension skills.
Excellent verbal and written communication skills in English.
Effective interpersonal skills for teamwork and collaboration.
Preferred / Nice-to-Have Skills
Prior experience or exposure in pharmacovigilance or medical safety operations.
Equal Opportunity Statement
Indegene is committed to inclusion and diversity and does not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other protected characteristic. Employment decisions are based on business requirements, candidate merit, and qualifications.
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