o 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)
o 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
o Developing and maintaining thorough knowledge of the appropriate disease biology areas & important safety concerns for marketed drugs and drugs in development
o Assuring and maintaining compliance with regulatory and local/global SOP timelines TCS Confidential
o Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing
o Representing safety physician team in internal and client safety forums and audits
Location
Mumbai
Job Function
BUSINESS PROCESS SERVICES
Role
Executive
Job Id
382817
Desired Skills
Medical Regulatory
Desired Candidate Profile
Qualifications
: MBBS, MD
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