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Medical Reviewer
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#401544
Full Time
Job Description
Job description
Main Job Tasks and Responsibilities:
• Awareness and understanding of relevant modules.
• Perform medical review of non-serious and serious with emphasis on seriousness, expectedness, causality & narrative, etc without missing on quality & compliance.
• Experience of medical review received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases, etc
• 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 MedDRA code, assess labelling and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
• Maintain Pharmacovigilance expertise and understanding of international safety regulations and guidelines.
• Responsible for completing the medical review activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Adapt to different client case processing conventions and multi-task as per business needs.
• Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.
Main Job Tasks and Responsibilities:
• Awareness and understanding of relevant modules.
• Perform medical review of non-serious and serious with emphasis on seriousness, expectedness, causality & narrative, etc without missing on quality & compliance.
• Experience of medical review received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases, etc
• 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 MedDRA code, assess labelling and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
• Maintain Pharmacovigilance expertise and understanding of international safety regulations and guidelines.
• Responsible for completing the medical review activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Adapt to different client case processing conventions and multi-task as per business needs.
• Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.
