Senior Drug Safety Physician

Indegene; Bengaluru; Hybrid; INR 1,200,000 - 2,000,000; Full time

Job summary

Indegene in Bengaluru is seeking an experienced PV professional to perform medical review and sign-off of safety cases in a hybrid work model. The role requires 3–6 years of dedicated Pharmacovigilance experience and an MBBS degree, with a focus on safety data analysis and literature surveillance.

You will review narratives, ensure regulatory compliance, and collaborate with stakeholders to support risk management and aggregate safety reporting.

Qualifications

• Strong hands-on experience in Pharmacovigilance and Drug Safety.
• Good knowledge of safety databases, PV processes and compliance requirements.
• Strong medical, analytical and critical-thinking skills.
• Excellent communication and interpersonal skills.
• Attention to detail and commitment to quality and timelines.

Responsibilities

• Medical review and assessment of ICRS, 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, feedback and guidance.

Skills

Pharmacovigilance

Drug Safety

Safety databases

PV processes

Communication skills

Analytical thinking

Attention to detail

Education

MBBS

Job description

Work Mode: Hybrid

Experience: 3-6 Years

Qualification: MBBS - Mandatory

• Medical review and assessment of ICRS, 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, feedback and guidance.

What We're Looking For

• Strong hands-on experience in Pharmacovigilance and Drug Safety.
• Good knowledge of safety databases, PV processes and compliance requirements.
• Strong medical, analytical and critical-thinking skills.
• Excellent communication and interpersonal skills.
• Attention to detail and commitment to quality and timelines.