TCS is Hiring
Roles : Medical Reviewer
Qualification: MBBS or MD
Roles & Responsibilities
Accountable for the medical review of relevant clinical, other solicited and spontaneous cases (including literature articles), medical assessment (including labeling and causality along with the company causality statement)
• Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history
• Developing and maintaining thorough knowledge of the appropriate disease biology areas & important safety concerns for marketed drugs and drugs in development
• Assuring and maintaining compliance with regulatory and local/global SOP timelines TCS Confidential
• Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing
• Representing safety physician team in internal and client safety forums and audits
• Review and respond to any queries/comments for an individual case safety report in the Patient Safety database.
• Responsible for generating, sending, and tracking medically relevant queries for follow-up information that is required for an individual case safety report
• Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Responsible Adverse reaction (SUSAR)
• Ensure compliance with global and local procedural documents and implementation of client and TCS, policies, procedures, and processes. Skills required:
• Computer Literate (e.g., knowledge of MS Office)
• Aptitude for self-directed learning
• Good medical knowledge and its application in drug safety
Thanks & Regards
Babeeta Shahi
📌 Medical Reviewer (Mumbai)
🏢 Tata Consultancy Services
📍 Mumbai
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