Job Title: Drug Safety Associate (Pharmacovigilance Officer I)
Date Posted: 29 August 2025
Location: Bangalore, Karnataka, India
About Indegene
Indegene is a technology-led healthcare solutions provider, enabling healthcare organizations to become future-ready. We operate at the intersection of healthcare and technology, driven by innovation, collaboration, empathy, and a passion for making a difference.
At Indegene, we offer a global, fast-track career path with opportunities to work with some of the most brilliant minds in the industry. We celebrate entrepreneurship and empower talent to grow with our high-speed trajectory.
For more details, visit: www.careers.indegene.com
Role Overview
As a Drug Safety Associate (Pharmacovigilance Officer I), you will be part of the Pharmacovigilance team responsible for handling safety data and reporting to ensure compliance with global regulatory standards.
Key Responsibilities
Confirm the validity of cases by identifying minimum criteria for case creation.
Perform duplicate checks to determine if the case is an initial or follow-up.
Apply principles of patient safety and understand global regulatory reporting requirements for 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 complaints
Attach relevant source documents and follow-up information to cases.
Coordinate follow-up based on data entry/QC/medical review queries or missing/inconsistent source information.
Perform medical coding (e.g., adverse events, medical history, indications, lab data) using standardized medical dictionaries such as MedDRA.
Code products (suspect, co-suspect, concomitant) in compliance with client conventions and regulatory requirements.
Draft high-quality narrative summaries for case reporting.
Candidate Profile
Must Have:
Knowledge of case-handling procedures and the overall drug research process.
Familiarity with pharmacovigilance regulatory requirements.
Strong cognitive abilities including:
Verbal reasoning
Attention to detail
Analytical and critical thinking
Sound understanding of medical terminology and therapeutic areas.
Good comprehension skills.
Effective verbal and written communication skills in English.
Strong interpersonal abilities.
Nice to Have:
Exposure to pharmacovigilance tools or databases.
Previous experience in drug safety or life sciences domain.
Perks and Benefits
Accelerated career growth in a fast-paced, high-impact environment.
Mentorship from industry experts.
Opportunities to work at the global intersection of healthcare and technology.
Equal Opportunity Statement
Indegene is proud to be an Equal Employment Opportunity (EEO) employer. We are committed to fostering a culture of inclusion and diversity.
All employment decisions—from hiring to separation—are based on business requirements, merit, and qualifications, without regard to race, religion, sex, color, age, national origin, pregnancy, sexual orientation, gender identity, disability status, veteran status, or any other legally protected characteristics.
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