Role: Medical Reviewer
Domain: Life Sciences
Minimum Qualification: MBBS or Equivalent
Preferred Experience:1 to 4 years of experience. 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
- 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 environment
