Clinical Reviewer
2 days ago
We are seeking a highly skilled Clinical Reviewer to join our team at Tata Consultancy Services.
About the Role:
The successful candidate will be responsible for medical review of non-serious and serious cases, including event assessment, seriousness evaluation, labeling & causality assessment, and accuracy verification of AE/SAE coding.
Key Responsibilities:
- Perform thorough medical reviews of case reports to ensure adherence to SOPs and User Manual guidelines.
- Evaluate the seriousness of adverse events, assess causality, and verify MedDRA and WHO-DD coding accuracy.
- Collaborate with internal stakeholders to confirm the accuracy of medical coding and narrative completeness.
- Author company- specific causality/case comment (CCC) and provide timely feedback on errors identified during review and correction.
- Manage mailboxes according to relevant working instructions and generate accurate initial/follow-up questionnaires.
- Requisition clarifications and additional PV information from customer affiliates and subcontractors within set timelines.
- Screen literature articles to identify potential safety signals and create ICSR as per user manual, SOPs, and relevant working instructions.
Requirements:
- 2 years to 3 years of experience in Pharmacovigilance/Clinical Experience.
- MBBS/MD qualification.
Location: Mumbai, India
Estimated Salary: ₹8.5 Lakhs - ₹12 Lakhs per annum, depending on experience and qualifications.
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