Sr. Drug Safety Physicians
Job Description
Responsibilities
Medical review of adverse events reported to investigational and marketed products including identification of event/s, confirmation of seriousness, ensure that events are coded and mapped to the appropriate terms in MedDRA, provide assessment of expectedness per reference safety information, assessment of causality, review of narrative for chronology and medical content and provide medical evaluation comment.
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.
Ensure regulatory compliance with respect to the evaluation, reporting and surveillance of safety information.
Identify, communicate, and effectively manage potential safety issues.
Provide medical safety analysis and interpretation for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, bridging reports, and other relevant aggregate report/analyses).
Interact with clients safety/medical personnel as appropriate to ensure above.
Maintain a working knowledge of projects in the functional area for which inVentiv Health Clinical safety is responsible for safety reporting.
Stay abreast of clinical and drug development information relevant to contracted programs by review of literature and by maintaining training.
Serve as a mentor for other internal safety staff including case processing staff.
Medical review of adverse events reported to investigational and marketed products including identification of event/s, confirmation of seriousness, ensure that events are coded and mapped to the appropriate terms in MedDRA, provide assessment of expectedness per reference safety information, assessment of causality, review of narrative for chronology and medical content and provide medical evaluation comment.
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.
Ensure regulatory compliance with respect to the evaluation, reporting and surveillance of safety information.
Identify, communicate, and effectively manage potential safety issues.
Provide medical safety analysis and interpretation for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, bridging reports, and other relevant aggregate report/analyses).
Interact with clients safety/medical personnel as appropriate to ensure above.
Maintain a working knowledge of projects in the functional area for which inVentiv Health Clinical safety is responsible for safety reporting.
Stay abreast of clinical and drug development information relevant to contracted programs by review of literature and by maintaining training.
Serve as a mentor for other internal safety staff including case processing staff.
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