Job Title:
Sr. Manager, GPS Aggregate Report Management and Risk Management Planning. this role will have Oversight and management of Aggregate Reports and Risk Management Plans
JOB DUTIES:
• Drives development and maintenance of Aggregate Reporting (i.e. PSURs/PBRER, PAER, DSURs, SUSARs) and Risk Management Deliverables.
• Leads Aggregate Report and Risk Management plans planning, production and distribution activities across GPS and other functions
• Provides expertise and guidance to authors and contributors of aggregate reports and risk management plans
• Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance
• Responsible for the implementation and management of effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality
• Oversee functional specifications of data requirements for aggregate deliverables from the safety and clinical databases
• Collaborates with Global Patient Safety (GPS) and with functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports
• Assists in preparation and support of audits and inspections
• Provides oversight, and training as needed, of CRO respective activities in support of high quality and timely aggregate reports
JOB REQUIREMENTS:
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