Medical Reviewer

TCS is hiring for Medical Reviewer roleMinimum Qualification: MBBS or MDPreferred Experience: Minimum of 9 months to 4 years of experience. Experience in PV/ ClinicalResearch (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 withthe company causality statement)• Review the medical sense including seriousness and coding of the case in the global context ofthe drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitantmedications, 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 timelinesTCS Confidential• Supporting the Drug Safety teams with medical concepts and awareness of product relatedtopics 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 PatientSafety database.• Responsible for generating, sending, and tracking medically relevant queries for follow-upinformation that is required for an individual case safety report• Provide product advice as required, especially with regards to case reports that are SuspectedUnexpected Serious Adverse reaction (SUSAR)• Ensure compliance with global and local procedural documents and implementation of clientSkills 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• Good 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 environmentRegardsManisha Singh(TCS -HR)