Job Title: Drug Safety Associate
Date Posted: 5 September 2025
Location: Bangalore, Karnataka, India
Company: Indegene
About Indegene:
Indegene is a technology-led healthcare solutions provider with a mission to make healthcare organizations future-ready. Our culture thrives on passion, innovation, collaboration, and empathy. We offer bold, industrious, and nimble talent the chance to accelerate their careers on a global scale.
At Indegene, you will:
Work at the intersection of healthcare and technology
Be mentored by experienced industry professionals
Embark on a fast-track, high-growth career journey
Experience a differentiated work environment focused on purpose and innovation
For more information, visit: www.careers.indegene.com
Position Overview:
As a Drug Safety Associate (Pharmacovigilance Officer I), you will be involved in the end-to-end safety case-handling process. This includes validating, processing, and coding safety information, as well as preparing narrative summaries in compliance with regulatory and client requirements.
Key Responsibilities:
Confirm the validity of safety cases by identifying minimum criteria for case creation
Conduct duplicate checks to determine whether a case is initial or follow-up
Understand and apply regulatory requirements for reporting individual case safety reports (ICSRs)
Identify serious adverse events (SAEs) and special scenarios such as:
Lack of efficacy
Exposure during pregnancy
At-risk cases
Product quality complaint-only cases
Attach relevant source documents and follow-up communications to case files
Facilitate follow-ups based on:
Queries from Data Entry, Quality Control, or Medical Review teams
Inconsistencies or missing data in the source documents
Perform medical coding using standardized dictionaries (e.g., MedDRA) for:
Adverse events
Medical history
Lab data
Indications
Code suspect, co-suspect, and concomitant products as per client and regulatory conventions
Draft clear, concise, and medically accurate case narratives
Qualifications & Requirements:
Must-Have:
Understanding of drug safety processes and pharmacovigilance regulations
Knowledge of the overall drug development and research process
Strong attention to detail and cognitive skills (e.g., verbal reasoning, critical and analytical thinking)
Proficiency in medical terminology and therapeutic areas
Good comprehension skills
Strong written and verbal communication skills in English
Ability to work collaboratively in a fast-paced, team-oriented environment
Nice-to-Have:
Familiarity with safety databases and tools
Prior experience in pharmacovigilance or healthcare-related domains
Equal Opportunity Statement:
Indegene is an Equal Opportunity Employer committed to a diverse and inclusive workplace.
We do not discriminate on the basis of:
Race, religion, color, age, gender, sexual orientation, national origin, disability, pregnancy, gender identity, veteran status, or any other legally protected status.
All employment decisions are based on business needs, qualifications, and merit.
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