Medical Reviewer

Medical Reviewer

Life Sciences

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.

s.laharika@tcs.com

Regards

Laharika - TCS HR