Job Title: Drug Safety Associate
Date Posted: 17 Sept 2025
Location: Bangalore, Karnataka, India
About the Company
Indegene is a technology-led healthcare solutions provider driven by the purpose of enabling healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that is bold, industrious, and nimble.
At Indegene, you will:
Work at the exciting intersection of healthcare and technology.
Be mentored by some of the most brilliant minds in the industry.
Build a strong career foundation with global, fast-track growth.
Thrive in a culture guided by passion, innovation, collaboration, and empathy.
Learn more at: www.careers.indegene.com
Position: Associate – Pharmacovigilance Officer I
Key Responsibilities
Confirm validity of cases by identifying minimum criteria for case creation.
Perform duplicate searches and create initial or follow-up cases.
Apply principles and concepts of patient safety case-handling, including regulatory requirements for Individual Case Safety Reports (ICSRs).
Identify and assess serious adverse events (SAEs) and special scenario cases (e.g., lack of efficacy, exposure, pregnancy, at-risk cases, product quality complaints).
Attach relevant source documents, safety information, queries, or follow-up details to cases.
Facilitate follow-up based on queries from Data Entry/QC/Medical Reviewer or incomplete source information.
Perform medical coding of adverse events, medical history, lab data, and indications using standardized terminology (e.g., MedDRA).
Code products (suspect/co-suspect/concomitant) in compliance with client conventions and regulatory requirements.
Draft accurate and concise case narratives.
Required Qualifications & Skills
Must Have:
Understanding of case-handling processes and the overall drug research process.
Cognitive abilities including verbal reasoning, attention to detail, analytical and critical thinking.
Good knowledge of therapy areas and medical terminology.
Strong comprehension, written, and verbal communication skills in English.
Interpersonal skills with the ability to work in a collaborative environment.
Nice to Have:
Additional knowledge or experience in drug safety or pharmacovigilance processes.
Familiarity with regulatory reporting guidelines.
Perks & Benefits
Opportunity to work in a global, high-growth organization.
Fast-track career development.
Exposure to cutting-edge healthcare technologies.
Equal Opportunity Statement
Indegene is an Equal Employment Employer committed to fostering a culture of inclusion and diversity.
We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. Employment decisions are based solely on business requirements, merit, and qualifications.
All qualified applicants will receive consideration without regard to race, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
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