Medical Reviewer

TCS is hiring for Medical Reviewer Role !!!

Minimum Qualification: MBBS or MD

Experience: 1 to 5 Years 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 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