Job Title: Drug Safety Associate (Associate – Pharmacovigilance Officer I)
Company: Indegene
Location: Bangalore, KA, India
Date Posted: 17 Sept 2025
Company Overview
Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. The company emphasizes global career growth, entrepreneurship, mentorship, and operates at the intersection of healthcare and technology.
Role Overview
The Drug Safety Associate will work within the Safety/Pharmacovigilance team, handling individual case safety reports (ICSRs), performing coding, and ensuring compliance with regulatory requirements. The role involves identifying, documenting, coding, and following up on adverse events and other safety-related information.
Key Responsibilities
Confirm the validity of safety cases by identifying minimum criteria for case creation.
Perform duplicate searches to create either an initial or follow-up case.
Understand patient safety case-handling principles, regulatory requirements, and concepts.
Identify serious adverse events and special scenario cases including:
Lack of efficacy
Exposure and pregnancy cases
At-risk cases
Product quality complaint-only cases
Attach relevant source documents, safety information, and follow-up details to cases.
Facilitate follow-up queries from data entry, QC, medical reviewers, or source documentation inconsistencies.
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: Medical, M.Pharm, Pharm.D, or Life Sciences degree.
Understand principles and concepts of case-handling and drug research processes.
Cognitive abilities including verbal reasoning, attention to detail, critical and analytical thinking.
Good knowledge of therapy areas and medical terminology.
Strong comprehension and communication skills (verbal and written) in English.
Good interpersonal skills.
Preferred / Nice-to-Have Skills
Prior experience in pharmacovigilance, medical coding, or drug 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. All employment decisions are based on business requirements, merit, and qualifications.
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