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Drug Safety Medical Reviewer
Drug Safety Medical ReviewerTata Consultancy Services • Republic Of India, IN
Drug Safety Medical Reviewer

Drug Safety Medical Reviewer

Tata Consultancy Services • Republic Of India, IN
4 days ago
Job description

Role : Medical Reviewer

Domain : Life Sciences

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
  • 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.

    Interested candidates are requested share updated CV with below details on the mail id s.laharika@tcs.com

    Regards

    Laharika - TCS HR

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    Drug Safety Reviewer • Republic Of India, IN

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