Senior Drug Safety Physician
Location: Karnataka, India
Employment Type: Full-Time | Hybrid/Office-Based
Posted Date: 15 Dec 2025
About Indegene
Indegene is a technology-driven healthcare solutions provider committed to enabling healthcare organizations to be future-ready. We empower global clients with innovative pharmacovigilance, drug safety, and healthcare technology solutions, delivering high-quality, compliant, and efficient outcomes. At Indegene, you will experience accelerated career growth, mentorship from industry experts, and exposure to cutting-edge drug safety and pharmacovigilance operations. Explore more at Indegene Careers.
Role Overview
The Senior Drug Safety Physician will oversee and manage the end-to-end pharmacovigilance process, ensuring timely, accurate, and regulatory-compliant reporting of adverse events. The ideal candidate will have a strong clinical background, understanding of drug safety regulations, and experience in case handling, coding, and narrative writing.
Key Responsibilities
Case Validation & Management: Confirm case validity by evaluating minimum criteria for case creation; perform duplicate searches and manage initial or follow-up cases.
Adverse Event Identification: Identify serious adverse events, special scenarios including lack of efficacy, exposure during pregnancy, at-risk cases, and product quality complaints.
Source Documentation: Attach relevant source documents, safety information, or follow-up data; facilitate queries and follow-ups from Data Entry, QC, or Medical Review teams.
Medical Coding: Accurately code adverse events, medical history, lab data, indications, and other relevant information using MedDRA or client-specific coding dictionaries.
Product Coding: Code suspect, co-suspect, and concomitant products in line with client conventions and regulatory requirements.
Narrative Writing: Draft high-quality, accurate, and regulatory-compliant narratives for safety cases.
Regulatory Compliance: Ensure adherence to global pharmacovigilance guidelines, local regulatory requirements, and client SOPs.
Collaborate with cross-functional teams including clinical operations, regulatory, and quality assurance to ensure timely and accurate safety reporting.
Required Qualifications & Experience
Education: MD / MBBS / equivalent clinical degree.
Experience: Minimum 5 years of experience in pharmacovigilance, drug safety, or clinical research, with hands-on case handling and safety reporting.
Strong knowledge of drug safety case-handling principles, pharmacovigilance processes, and global regulatory requirements.
Solid understanding of medical terminology and therapy areas.
Excellent verbal and written communication skills in English.
Critical thinking, analytical skills, and attention to detail for accurate case assessment.
Preferred Qualifications
Prior experience in narrative writing, medical coding (MedDRA), and adverse event reporting.
Familiarity with global regulatory guidelines including ICH, FDA, EMA, and local pharmacovigilance regulations.
Experience working in pharmaceutical companies, CROs, or medical communications agencies.
Why Join Indegene
Work with a global healthcare leader driving innovation in drug safety and pharmacovigilance.
Accelerated career growth through exposure to complex projects and global clients.
Collaborative and inclusive culture that values expertise, innovation, and continuous learning.
Opportunities to work on cutting-edge safety case management systems, regulatory reporting tools, and clinical data analytics.
Equal Opportunity Statement
Indegene is an Equal Employment Opportunity Employer, committed to inclusion and diversity. Employment decisions are based on merit, qualifications, and business requirements. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any legally protected characteristics.
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