+ The PSSR Aggregate Reports Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments, Risk Management Plans and relevant documents, and other documents in support of safety changes to labeling documents.
+ Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents.
+ Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
+ Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a particular project.
+ Support WSR teams by providing analyses of post-marketing safety data, reviews of the medical literature, and similar related activities.
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