Title: Senior Drug Safety Physician
Location: Karnataka, India
Date Posted: 15 Dec 2025
Job Type: Full-Time
Category: Pharmacovigilance / Drug Safety
Company Overview:
Indegene is a technology-led healthcare solutions provider, committed to enabling healthcare organizations to be future-ready. We offer a dynamic career path that combines healthcare and technology, fostering innovation, collaboration, and rapid professional growth. Our culture emphasizes entrepreneurship, customer obsession, and delivering impactful solutions globally. Explore opportunities at Indegene Careers.
Role Overview:
We are seeking an experienced Senior Drug Safety Physician to provide medical oversight and review of Individual Case Safety Reports (ICSRs) and other pharmacovigilance activities. The role involves case evaluation, causality assessment, aggregate safety review, and contributing to global risk management strategies, ensuring compliance with regulatory requirements and client expectations.
Key Responsibilities:
Medical Review & Case Assessment:
Perform medical review of ICSRs for accuracy, relevance, and completeness in alignment with client requirements.
Evaluate adverse events (AE) for seriousness, listedness, and ensure all medically relevant information is captured.
Conduct causality assessments for reported AEs and SAEs using global clinical methodologies.
Review case narratives, coding, product labeling, and medical histories to ensure completeness and regulatory compliance.
Provide medical sign-off and perform line listing reviews for non-serious cases.
Conduct unblinding activities, literature surveillance, and Analyses of Similar Events (AOSE) as required.
Aggregate Safety & Risk Management:
Review and analyze safety data from clinical trials, post-marketing, and literature sources.
Contribute to pharmacovigilance and risk management planning for designated products.
Provide safety assessments and risk/benefit evaluations across product lifecycle stages.
Develop and update Standard Operating Procedures (SOPs) and support global compliance initiatives.
Quality & Compliance:
Monitor activities of data entry and QC reviewers, providing feedback and guidance to maintain quality standards.
Ensure compliance with international pharmacovigilance regulations, company SOPs, and departmental practices.
Participate in Governance and team meetings, internal trainings, and client trainings as required.
Track and communicate observations to stakeholders and support root cause analysis (RCA) and corrective/preventive actions (CAPA).
Required Qualifications & Skills:
Strong cognitive abilities including attention to detail, critical thinking, and analytical skills.
Solid understanding of disease pathology, physiology, pharmacology, and therapeutics.
Experience in pharmacovigilance with proficiency in safety database operations and compliance activities.
Ability to mentor, train, and guide team members effectively.
Excellent communication, interpersonal, and organizational skills.
Preferred:
Familiarity with pharmaceutical drug development and pharmacovigilance principles.
Demonstrated track record in medical review, case assessment, and safety database management.
Why Join Indegene:
Work at the intersection of healthcare and technology on a global scale.
Benefit from mentorship by industry experts and accelerated career growth.
Contribute to impactful pharmacovigilance strategies and patient safety initiatives.
Equal Opportunity Statement:
Indegene is committed to fostering an inclusive and diverse workplace. Employment decisions are based on merit, qualifications, and business requirements, without regard to race, religion, gender, sexual orientation, disability, or other legally protected characteristics.
Apply Now: Take your pharmacovigilance career to the next level as a Senior Drug Safety Physician at Indegene, Karnataka.
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