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About the role & responsibilities
• Review and contribute to Safety Data Exchange Agreements ensuring quality and compliance
• Support preparation of licensing agreements within assigned therapeutic areas
• Participate in internal project-focused medical safety meetings
• Engage in external scientific and non-regulatory meetings with consultants and partners
• Maintain audit and inspection readiness
• Lead or support safety process improvement initiatives
• Provide medical safety support for US and RoW case management functions
• Review and approve investigator safety reports with Clinical Development physicians
Qualification
• MBBS / MD
Experience
• Minimum 3 years in signal management, safety report authoring and benefit–risk management planning
Skills
• Signal management
• Safety report writing and review
• Benefit–risk evaluation
• Regulatory compliance understanding
• Strong analytical and communication skills
About the company
• Tata Consultancy Services (TCS) is a global IT and digital transformation leader with strong life sciences and healthcare operations