Awareness and understanding of relevant GVP modules.
Perform medical review of non-serious & serious ICSRs with emphasis on seriousness
Experience of medical review of ICSRs received from sources such as Spontaneous, Literature
Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology
Support triage of cases and determine seriousness and relatedness across products as assigned.
Review and verify appropriate selection of adverse events from source documents, assign appropriate

🎯 Requirements

Should be a MBBS/MD with 2- 4 years of experience as Medical Reviewer for ICSRs.
Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other
Training and mentoring skill (GVP concepts & medical aspects such as disease condition, product
Must have hands on experience with MS Office applications (Outlook, Excel, Word, Power Point etc)

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