Role: Medical Reviewer

Minimum Qualification: MBBS or MD

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

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

Medical Reviewer