Medical reviewer

TCS is hiring for Medical Reviewer!!!

Job Location – Kochi

Experience Range – 1 to 5 Years

Educational Qualification(s) Required – MBBS/MD

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 

•           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.