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.

:
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 &

significant 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
Positive problem solving and decision-making skills
Initiative-taking, able to prioritize and plan effectively
Excellent interpersonal and communication skills
Team player with ability to function in a multi – disciplinary workplace

Regards

Manisha Singh(TCS -HR)

📌 Medical Reviewer Mumbai
🏢 Tata Consultancy Services
📍 Mumbai