Sr Mgr. Drug Safety
2 weeks ago
Job Title: Sr Mgr. Drug Safety & Public Health - V
Location: 100% Remote
Duration: 12 Months (Possible Extension)
Job Description:
Role Expectations
• Generate Evidence Plan for a new molecule and/or disease area with cross-functional drug development teams
• Assess RWD and clinical trial datasets for new molecule and/or disease area
• Support launch planning using RWE/RWD
• Support regulatory submissions and respond to regulatory queries
• Develop proposals for post-marketing commitments with the drug development teams and safety
• Participate and contribute to program or study planning meetings
• Perform feasibility analysis for studies
• Plan observational studies and draft protocol synopsis (or protocol concept sheet)
• Determine observational study design criteria – including source data, analytical methods and analysis plans
• Draft and review observational study protocols
• Draft and review observational study analysis specifications, including statistical analysis plans (SAPs)
• Draft and review observational study reports
• Conduct observational studies, both primary data collection and secondary data use studies
• Review analysis outputs for quality, including study analysis, ad hoc analysis, analysis to support conference or publications
• Conduct quality review of all deliverables to ensure data and results are accurate
• Work with scientific and operational stakeholders to identify and resolve issues
• Collaborate with study teams, vendors and other stakeholders to advance study and analysis deliverables
• Work with relevant stakeholders to meet study milestones and timelines
• Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks
• Perform other related duties as required by the Department.
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