Medical Reviewer

Job description

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. **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 Regards Manisha Singh(TCS -HR)