Medical Reviewer

Medical Reviewer

MBBS or Equivalent Preferred

Minimum of 9 months to 4 years of experience.

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.

• 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