Medical Specialist
About the Role
Role & Responsibilities
• Perform medical review of clinical, solicited, spontaneous, and literature safety cases
• Conduct medical assessment including seriousness, expectedness, labeling, and causality evaluation
• Review and validate AE/SAE terms, suspect drugs, concomitant medications, lab data, and medical history
• Ensure accurate narrative review and global coding consistency
• Develop and maintain strong knowledge of disease biology and key safety concerns for marketed and investigational products
• Ensure compliance with global regulatory requirements and internal SOP timelines
Qualification
• MBBS or equivalent medical qualification
Experience
• Experience in pharmacovigilance / medical review domain preferred
Skills
• Strong knowledge of PV regulations and safety case processing
• Medical assessment and causality evaluation expertise
• MedDRA coding and narrative review skills
• High attention to detail and regulatory compliance awareness
• Good communication and documentation skills
About the Company
TCS (Tata Consultancy Services) is a global IT services and consulting leader with a strong Life Sciences practice supporting pharmaceutical and healthcare organizations worldwide through advanced technology, analytics, and compliance-driven solutions.
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