Job Description

Role: Medical Reviewer



Experience: 2-5



Minimum Qualification: MBBS/MD



:


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

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

Location

Mumbai

Job Function

BUSINESS PROCESS SERVICES

Role

Executive

Job Id

379725

Desired Skills

Medical Knowledge
Desired Candidate Profile

Qualifications

: MBBS, MD