Performance of alert triage within pre-defined timelines, by conducting systematic reviews of cases and aggregate data in the safety databases and reviewing trends, as applicable, to identify potential safety signals.
Performance of signal validation and support for signal evaluation through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as clinical, post marketing, observational studies, medical literature, health authority databases, and product quality databases.
Assistance in the development and implementation of strategies for the surveillance of post-marketing data, as well as the development of product specific medical safety assessments.
Participation as a member of the matrix teams to address product-specific safety issues.
Support for the evaluation of novel and computer-assisted tools and methodologies for the analysis of safet...