Role & Responsibilities
• Perform medical review of aggregate safety reports to ensure accuracy, consistency, and regulatory compliance
• Review and assess Individual Case Safety Reports (ICSRs) in line with global pharmacovigilance standards
• Analyse signal reports and provide medical interpretation, insights, and recommendations
• Contribute to the preparation, review, and maintenance of Risk Management Plans (RMPs)
• Support benefit–risk evaluation activities for assigned products
• Ensure compliance with global PV regulations, guidelines, and internal SOPs
• Collaborate with cross-functional teams including PV operations, regulatory affairs, and quality
• Maintain high standards of documentation, medical judgment, and review quality
Qualification
• MBBS or MD
Experience
• Minimum 2+ years of experience in Drug Safety / Pharmacovigilance / Medical Review
Skills
• Strong understanding of pharmacovigilance processes and safety reporting
• Knowledge of aggregate reports, signal detection, and risk management activities
• Familiarity with global PV regulations and guidelines
• Strong analytical, medical review, and documentation skills
• Ability to work effectively in an office-based, cross-functional environment
About the Company
• Fresenius Kabi Oncology Limited is part of a global healthcare group dedicated to advancing life-saving medicines and technologies
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