Job Title: Drug Safety Associate
Date Posted: 29 Aug 2025
Location: Bangalore, KA, India
Company Overview:
Indegene is a technology-led healthcare solutions provider that enables healthcare organizations to be future-ready. The company offers accelerated global growth opportunities for talent that is bold, industrious, and nimble. At Indegene, employees gain a unique career experience guided by passion, innovation, collaboration, and empathy.
Key highlights:
Mentorship from industry experts
Exposure to the intersection of healthcare and technology
Global fast-track career growth opportunities
Job Summary:
The Drug Safety Associate (Pharmacovigilance Officer I) will support pharmacovigilance operations by processing, reviewing, and coding safety cases while ensuring compliance with regulatory standards. The role includes case validation, adverse event reporting, and drafting narratives for individual case safety reports (ICSRs).
Key Responsibilities:
Confirm validity of cases by identifying minimum criteria for case creation.
Perform duplicate searches to create initial or follow-up cases.
Understand and apply principles of patient safety case-handling, including regulatory requirements for ICSRs.
Identify serious adverse events (SAEs) and special scenario cases, including:
Lack of efficacy
Exposure and pregnancy cases
At-risk cases
Product quality complaint-only cases
Attach relevant source documents and any additional safety information.
Facilitate follow-ups based on queries from Data Entry, Quality Control (QC), or Medical Review (MR) regarding missing or inconsistent information.
Perform medical coding (Adverse Events, Medical History, Lab Data, Indications) using standardized dictionaries, such as MedDRA.
Code products (Suspect/Co-suspect, Concomitant) as per client conventions and regulatory requirements.
Draft case narratives according to standards.
Required Skills & Qualifications:
Understanding of case-handling processes and overall drug research process.
Strong cognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical skills.
Knowledge of therapy areas and medical terminology.
Good comprehension and problem-solving skills.
Effective verbal and written communication skills in English.
Strong interpersonal skills.
Nice to Have (Optional):
Experience in pharmacovigilance or regulatory compliance
Exposure to multiple therapeutic areas
Work Environment & Perks:
Opportunity to work in a fast-paced healthcare technology environment.
Exposure to pharmacovigilance operations across multiple therapeutic areas.
Collaborative work culture with mentorship and learning opportunities.
Equal Opportunity Employer:
Indegene is committed to a culture of inclusion and diversity. Employment decisions are based on business requirements, merit, and qualifications.
All qualified applicants will receive consideration without regard to:
Race, color, religion, sex, national origin
Gender identity or sexual orientation
Disability status or protected veteran status
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