Manager Aggregate Reports Analyst

The PSSR Aggregate Report 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, and Risk Management Plans and relevant documents. Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and 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. Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e.g., Canadian Annual Report).

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.