Drug Safety Medical ReviewerTata Consultancy Services • Republic Of India, IN
Drug Safety Medical Reviewer
Tata Consultancy Services • Republic Of India, IN
1 day ago
Job descriptionReview the medical sense including seriousness and coding of the case in the global context of Developing and maintaining thorough knowledge of the appropriate disease biology areas & 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
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)
the drug or clinical project, including the narrative, AE / SAE terms, suspect drugs, concomitant
medications, laboratory data, and medical history
important safety concerns for marketed drugs and drugs in development
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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