Medical Reviewer (Mumbai)

Medical Reviewer (Mumbai)

10 Aug
|
Tata Consultancy Services
|
Mumbai

10 Aug

Tata Consultancy Services

Mumbai

TCS is hiring for Medical Reviewer role
Minimum Qualification: MBBS or MD
Preferred Experience: Minimum of 9 months to 4 years of experience. Experience in PV/ Clinical
Research (drug safety) preferred.

Job Description:

• 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 Serious Adverse reaction (SUSAR)
• Ensure compliance with global and local procedural documents and implementation of client

Skills required:
• Computer Literate (e.g., knowledge of MS Office)
• Aptitude for self-directed learning
• Good medical knowledge and its application in drug safety
• Sound understanding of the Drug Safety and Regulatory process
• Valuable problem solving and decision-making skills
• Initiative-taking, able

📌 Medical Reviewer (Mumbai)
🏢 Tata Consultancy Services
📍 Mumbai

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