About the role
TCS is hiring for Medical Reviewer role
Domain: Life Sciences
Minimum Qualification: MBBS or Equivalent Preferred Experience: Minimum of 9 months 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
Qualifications: MBBS, MD