Senior Drug Safety Physician
Location: Karnataka, India
Employment Type: Full-Time
Function: Pharmacovigilance / Drug Safety
Experience Required: 6–10 Years
Date Posted: 13 January 2026
Job Overview
Indegene, a technology-led healthcare solutions provider, is seeking a highly experienced Senior Drug Safety Physician to lead medical review and safety assessment activities across global pharmacovigilance programs. This role is critical in ensuring medical accuracy, regulatory compliance, and high-quality safety surveillance across clinical and post-marketing environments.
The position offers the opportunity to work at the intersection of healthcare, technology, and global safety operations, contributing to robust risk management and patient safety outcomes.
Key Responsibilities
Perform comprehensive medical review of Individual Case Safety Reports (ICSRs) to ensure accuracy, clinical relevance, and consistency with supporting source documents and client requirements.
Evaluate adverse events (AEs) and serious adverse events (SAEs) for seriousness, listedness, completeness, and regulatory compliance.
Conduct company causality assessments using clinical judgment and globally accepted introspection methodologies in alignment with international pharmacovigilance regulations.
Review case narratives, medical coding, product and indication mapping, labeling, medical history, and reference safety documents for completeness and accuracy.
Provide formal medical sign-off on safety cases within defined timelines.
Perform line listing reviews for non-serious cases to validate appropriate event evaluation, coding, and labeling.
Execute unblinding activities when applicable and in compliance with study protocols.
Ensure appropriate and timely follow-up queries and questionnaires are issued based on case assessment.
Conduct literature surveillance and review safety data from scientific publications when required.
Review Analyses of Similar Events (AOSE) for expedited reporting in accordance with regulatory expectations.
Provide aggregate safety reviews across clinical trials, post-marketing surveillance, and literature sources.
Identify inconsistencies in data entry and quality control activities; provide structured feedback and improvement recommendations to maintain quality standards.
Contribute to pharmacovigilance and risk management planning, including safety surveillance strategies and issue tracking.
Review safety assessments and benefit-risk evaluations, providing expert medical input across safety lifecycle stages.
Author, review, and update Standard Operating Procedures (SOPs) and support global quality and compliance initiatives.
Communicate safety observations to internal and external stakeholders, supporting root cause analysis (RCA) and corrective and preventive actions (CAPA).
Present quality and safety metrics to internal governance forums as required.
Participate in internal, regulatory, and client-mandated training programs and governance meetings.
Required Skills & Competencies
Strong cognitive abilities including clinical reasoning, attention to detail, critical thinking, and scientific accuracy.
Excellent analytical and problem-solving skills with the ability to evaluate complex safety data.
Strong understanding of disease pathology, physiology, pharmacology, and therapeutics.
Proven expertise in global pharmacovigilance regulations and safety database operations.
Ability to interpret project requirements and deliver outcomes aligned with quality and compliance expectations.
Effective communication, mentoring, and stakeholder engagement skills.
Demonstrated ability to drive quality, meet deadlines, and support team performance in high-volume environments.
Qualifications & Experience
Medical Degree: MBBS / MD or equivalent from a recognized institution.
Experience:
Minimum 6–10 years of experience in pharmacovigilance, drug safety, or medical review roles.
Strong track record in ICSR medical review, aggregate reporting, and regulatory compliance activities.
Prior exposure to safety databases, global PV compliance frameworks, and risk management activities is required.
Experience in pharmaceutical, biotech, CRO, or healthcare services environments is preferred.
About Indegene
Indegene is a purpose-driven, technology-enabled healthcare solutions organization helping global healthcare companies become future-ready. With a strong focus on innovation, collaboration, and customer-centricity, Indegene offers accelerated global career growth opportunities at the convergence of healthcare and technology.
Equal Employment Opportunity
Indegene is an Equal Opportunity Employer committed to inclusion and diversity. All employment decisions are based on business requirements, merit, and qualifications, without discrimination on any legally protected basis.
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