Senior Drug Safety Physician

Indegene; Bengaluru Urban; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Indegene is seeking a Medical Review Specialist for Pharmacovigilance in Bengaluru to handle safety case reviews, sign-offs, and risk assessments. You will contribute to literature surveillance and ensure compliance with global PV regulations and SOPs.

The role requires MBBS with MCI/NMC, 3–6 years of PV/Drug Safety experience, and hands-on experience with Argus Safety or ARISg. Strong analytical and communication skills are essential.

Qualifications

• MBBS with valid NMC/MCI registration and eligibility to practice in India.
• 3–6 years of pharmacovigilance/drug safety experience including medical review of ICSRs.
• Hands-on experience with Argus Safety and/or ARISg preferred.
• Strong analytical, critical-thinking and communication skills.

Responsibilities

• Medical review and assessment of ICSRs, including seriousness, listedness and causality.
• Review case narratives, coding, labeling, medical history and supporting documents.
• Perform medical sign-off and quality review of safety cases.
• Support literature surveillance and safety data analysis.

Skills

Medical review

Pharmacovigilance

Adverse events

Regulatory knowledge

Communication

Education

MBBS with MCI/NMC

Tools

Argus Safety

ARISg

Job description

Medical review and assessment of ICSRs, including seriousness, listedness and causality. Review case narratives, coding, labeling, medical history and supporting documents. Perform medical sign-off and quality review of safety cases. Support literature surveillance and safety data analysis. Contribute to aggregate safety reporting, safety assessments and risk management activities. Ensure compliance with global Pharmacovigilance regulations, SOPs and quality standards. Collaborate with stakeholders and provide medical expertise and guidance.

MBBS with valid NMC/MCI registration and eligibility to practice in India. 3–6 years of relevant Pharmacovigilance/Drug Safety experience, including medical review of ICSRs. Hands-on experience with Argus Safety and/or ARISg preferred. Strong understanding of global drug safety processes, regulatory requirements and medical assessment of adverse events. Good knowledge of safety databases, PV processes and compliance requirements. Strong analytical, critical-thinking and communication skills. High attention to detail with a strong focus on quality and timelines.