Senior Drug Safety Physician

Roles & Responsibilities
• Perform medical review of ICSRs ensuring accuracy, medical relevance, and consistency with source documents
• Evaluate adverse events (AE) and serious adverse events (SAE) for seriousness, listedness, and completeness
• Conduct company causality assessments aligned with global pharmacovigilance regulations
• Review case narratives, coding, labeling, product/indication details, and medical history for completeness and accuracy
• Provide medical sign-off on safety cases
• Conduct line listing review of non-serious cases and verify coding and labeling accuracy
• Perform unblinding activities as applicable
• Ensure appropriate follow-up questionnaires are initiated when required
• Conduct literature surveillance when applicable
• Review Analyses of Similar Events (AOSE) for expedited regulatory cases
• Provide aggregate safety reviews including clinical, post-marketing, and literature data
• Track inconsistencies identified during data entry and QC review and provide quality improvement feedback
• Contribute to safety surveillance strategies and risk management planning
• Review safety assessments and benefit-risk evaluations from a medical perspective
• Author and update SOPs and support global quality and compliance initiatives
• Communicate findings to stakeholders and ensure RCA/CAPA implementation
• Present QA and safety data in governance and internal review meetings
• Ensure compliance with international pharmacovigilance regulations and company SOPs

Qualification
• Degree in Medicine (MBBS preferred)
• Strong knowledge of disease pathology, physiology, pharmacology, and therapeutics
• Sound understanding of pharmacovigilance safety databases and compliance processes

Experience
• 1+ years experience in Drug Safety / Pharmacovigilance
• Prior experience in medical review of ICSRs preferred
• Exposure to global pharmacovigilance regulations desirable

Skills
• Strong analytical and critical thinking ability
• High attention to detail and scientific accuracy
• Good verbal reasoning and comprehension skills
• Effective communication and interpersonal skills
• Ability to meet deadlines and maintain quality standards
• Knowledge of drug development and pharmacovigilance processes
• Mentoring and training capability

About the Company
Indegene is a global healthcare solutions company that partners with life sciences and pharmaceutical organizations to drive commercialization, medical affairs, pharmacovigilance, and digital transformation initiatives. The company combines medical expertise, technology, and analytics to support drug development, safety monitoring, and patient-centric healthcare solutions worldwide.