Senior Drug Safety Physician
Location: Karnataka, India
Category: Pharmacovigilance / Drug Safety
Job Type: Full-Time
Experience Required: Senior-level (8+ years in Pharmacovigilance/Drug Safety)
Posting Date: 15 December 2025
About the Company
Indegene is a technology-led healthcare solutions provider committed to enabling healthcare organizations to become future-ready. Operating at the intersection of healthcare, life sciences, and technology, Indegene offers accelerated global career growth for professionals who are bold, agile, and purpose-driven.
At Indegene, you will work alongside industry-leading experts, contribute to global pharmacovigilance programs, and play a critical role in ensuring patient safety and regulatory compliance. The organization fosters a culture of innovation, collaboration, and continuous learning while delivering high-impact solutions to global pharmaceutical and biotech clients.
Role Overview
Indegene is seeking an experienced Senior Drug Safety Physician to lead medical review and safety evaluation activities across global pharmacovigilance programs. This role is critical in ensuring the scientific accuracy, regulatory compliance, and medical integrity of individual case safety reports (ICSRs), aggregate safety data, and risk management activities.
The position requires strong clinical judgment, in-depth pharmacovigilance expertise, and the ability to mentor teams while driving quality and compliance across safety operations.
Key Responsibilities
Perform comprehensive medical review of Individual Case Safety Reports (ICSRs) for accuracy, medical relevance, and consistency with source documents and regulatory requirements
Evaluate adverse events (AEs) and serious adverse events (SAEs) for seriousness, listedness, causality, and medical significance
Conduct company causality assessments using clinical judgment and global safety evaluation methodologies
Review case narratives, MedDRA coding, product/indication details, labeling, and medical history for completeness and scientific accuracy
Provide medical sign-off on safety cases in accordance with global regulatory standards
Perform line listing reviews of non-serious cases and confirm appropriate evaluation and coding
Execute unblinding activities when applicable
Ensure appropriate follow-up queries and medical questionnaires are issued
Conduct literature surveillance and medical review of published safety data as required
Review Analyses of Similar Events (AOSE) for expedited reporting
Contribute to aggregate safety reviews, including clinical trial data, post-marketing safety, and literature
Identify quality gaps, provide feedback to data entry and QC teams, and support continuous quality improvement
Ensure compliance with global pharmacovigilance regulations, SOPs, and internal quality standards
Support risk management planning, safety surveillance strategies, and benefit-risk assessments
Review, author, and update SOPs and contribute to global quality and compliance initiatives
Communicate safety findings to internal and external stakeholders and support RCA and CAPA activities
Present safety and QA metrics to leadership and governance forums
Participate in internal and client audits, governance meetings, and required training programs
Required Qualifications & Experience
Medical degree (MBBS / MD or equivalent)
8+ years of hands-on experience in pharmacovigilance or drug safety, including medical review of ICSRs
Strong expertise in global safety regulations (ICH, GVP, FDA, EMA)
Proven experience with safety databases, case processing, and compliance activities
Excellent understanding of disease pathology, pharmacology, and therapeutics
Demonstrated ability to perform causality assessments and benefit-risk evaluations
Strong analytical, critical thinking, and attention-to-detail skills
Excellent written and verbal communication skills
Experience mentoring and guiding safety teams
Ability to manage multiple priorities and meet regulatory timelines
Preferred Skills
Experience with aggregate reporting, signal detection, and risk management plans
Prior exposure to global client-facing pharmacovigilance programs
Knowledge of clinical development and post-marketing safety surveillance
Key Competencies
Scientific and medical accuracy
Regulatory compliance mindset
Quality-driven decision-making
Strong stakeholder communication
Leadership and mentoring capability
High level of professionalism and integrity
Equal Opportunity Statement
Indegene is an Equal Opportunity Employer and is committed to fostering an inclusive and diverse workplace. Employment decisions are based solely on business needs, qualifications, and merit, without discrimination on the basis of race, religion, gender, age, disability, sexual orientation, or any other protected characteristic.
SEO & GEO Optimized Keywords
Senior Drug Safety Physician India, Pharmacovigilance Physician Karnataka, Drug Safety Jobs India, ICSR Medical Review Jobs, PV Physician Roles India, Indegene Careers Pharmacovigilance, Global Drug Safety Physician India.
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