Job Description

TCS is hiring for Medical Reviewer!!!
Job Location - Pune
Experience Range - 1 to 3 Years
Educational Qualification(s) Required - MBBS/ MD



Roles and Responsibilities
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 timeline
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 Review and respond to any queries/comments for an individual case safety report in the Patient Safety database.
o Responsible for generating, sending, and tracking medically relevant queries for follow-up information that is required for an individual case safety report
o Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR)
o Ensure compliance with global and local procedural documents and implementation of client and TCS, policies, procedures, and processes

Location

Pune

Job Function

BUSINESS PROCESS SERVICES

Role

Executive

Job Id

383570

Desired Skills

Medical Regulatory
Desired Candidate Profile

Qualifications

: MBBS, MD