Drug Safety Associate
Date Posted: 29 Aug 2025
Location: Bangalore, KA, India
Company Overview
Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. We offer accelerated global growth opportunities for talent that is bold, industrious, and nimble.
Work at the intersection of healthcare and technology.
Mentorship from industry leaders.
Fast-track career growth aligned with Indegene’s expansion.
Purpose-driven culture with a focus on customer success.
Learn more: www.careers.indegene.com
Role Overview
The Drug Safety Associate (also referred to as Associate - Pharmacovigilance Officer I) is responsible for supporting patient safety case handling in compliance with global pharmacovigilance (PV) requirements. This role ensures accurate case documentation, coding, and reporting while supporting follow-up activities and narrative preparation.
Key Responsibilities
Case Management
Confirm validity of cases by identifying minimum criteria for case creation.
Perform duplicate searches to determine initial or follow-up case creation.
Identify serious adverse events (SAEs) and special scenario cases, including:
Lack of efficacy
Exposure and pregnancy
At-risk cases
Product quality complaint-only cases
Attach relevant source documents and safety information.
Facilitate follow-ups for queries from Data Entry/QC/Medical Review teams or for inconsistent/missing source data.
Coding & Documentation
Code adverse events, medical history, lab data, indications, etc., using standardized medical dictionaries such as MedDRA.
Code products (Suspect/Co-suspect, Concomitant) as per client conventions and regulatory requirements.
Draft case narratives for regulatory and internal review.
Requirements
Must-Have
Understanding of case-handling processes and the overall drug research process.
Cognitive abilities including verbal reasoning, attention to detail, and analytical thinking.
Knowledge of therapy area and medical terminology.
Strong comprehension and verbal/written communication skills in English.
Interpersonal skills to collaborate effectively with internal teams.
Nice-to-Have
Additional experience or certifications in pharmacovigilance or related quality processes.
Work Environment & Skills
Attention to detail and critical thinking.
Ability to work in a structured and regulated environment.
Comfortable with documentation, coding, and case review tasks.
Equal Opportunity Statement
Indegene is an Equal Employment Employer and promotes a culture of Inclusion and Diversity. Employment decisions are based on business requirements, candidate merit, and qualifications, without regard to:
Race, colour, religion, sex, age, national origin
Pregnancy, sexual orientation, gender identity
Physical ability, disability, or protected veteran status
All qualified applicants will receive consideration without discrimination.
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