Job Title: Drug Safety Associate (Associate – Pharmacovigilance Officer I)
Company: Indegene
Location: Pune, MH, India
Date Posted: 20 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 opportunities, entrepreneurship, mentorship, and operates at the intersection of healthcare and technology.
Role Overview
The Drug Safety Associate is responsible for handling individual case safety reports (ICSRs), performing case coding, ensuring regulatory compliance, and supporting pharmacovigilance activities 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 patient safety case-handling principles and regulatory requirements for ICSRs.
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, or follow-up information to cases.
Facilitate follow-up queries from Data Entry, QC, Medical Reviewers, or based on inconsistent/missing source data.
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)
Understanding of case-handling principles and the overall drug research process.
Cognitive abilities: verbal reasoning, attention to detail, critical and analytical thinking.
Good knowledge of therapy areas and medical terminology.
Strong comprehension, verbal, and written communication skills in English.
Interpersonal skills for effective teamwork and collaboration.
Preferred / Nice-to-Have Skills
Prior experience 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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