TCS is Hiring Roles : Medical Reviewer Qualification: MBBS or MD

Roles & Responsibilities

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 and TCS, policies, procedures, and processes.

Skills required

- Computer Literate (e.g., knowledge of MS Office)
- Aptitude for self-directed learning • Positive medical knowledge and its application in drug safety Thanks & Regards Babeeta Shahi

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