Medical Reviewer

11 hours ago

Mumbai, Maharashtra, India Tata Consultancy Services (TCS) Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role: Medical Reviewer

Experience: 2-5

Minimum Qualification: MBBS/MD

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

Location

Mumbai

Job Function

BUSINESS PROCESS SERVICES

Role

Executive

Job Id

379725

Desired Skills

Medical Knowledge

Desired Candidate Profile

Qualifications : MBBS, MD

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