TCS is hiring for Medical Reviewer role

Minimum Qualification: MBBS or MD

Preferred Experience: Minimum of 9 months to 4 years of experience. Experience in PV/ Clinical

Research (drug safety) preferred.

:

- 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
- Positive 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

Regards

Manisha Singh(TCS -HR)

📌 Medical Reviewer (Mumbai)
🏢 Tata Consultancy Services
📍 Mumbai