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TCS is a prominent name in the IT and healthcare industries, offering cutting-edge solutions and opportunities for professionals to thrive. Known for its innovation, TCS supports various industries, including life sciences, by providing transformative solutions and driving excellence.
Responsibilities of the Medical Reviewer
The Medical Reviewer will play a critical role in ensuring compliance with regulatory standards and enhancing pharmacovigilance processes. Key responsibilities include:
- Medical Review and Evaluation:
- Review non-serious and serious cases, special situations without adverse events, and non-valid cases according to SOPs and working instructions.
- Perform event assessment, check seriousness, and conduct labeling and causality assessments.
- Accuracy and Consistency:
- Verify the accuracy of medical coding, including MedDRA and WHO-DD coding.
- Ensure narratives are cohesive, complete, and free of errors.
- Case Management:
- Author company causality case comments (CCC).
- Determine and manage additional actions, including follow-up queries.
- Manage mailboxes as per instructions and ensure proper documentation.
- Quality Assurance:
- Provide timely feedback to associates to improve accuracy.
- Screen literature articles for potential safety signals and ensure ICSR creation.
Qualifications
Candidates must meet the following requirements:
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- Education: MBBS or MD degree.
- Experience: 2–3 years of experience in pharmacovigilance or clinical roles.
Skills
- Expertise in pharmacovigilance processes and case review.
- Strong knowledge of MedDRA and WHO-DD coding.
- Proficient in assessing narratives and performing causality evaluations.
- Attention to detail and ability to manage timelines.
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