The Director of Global Patient Safety (GPS), Aggregate Report Management and Risk Management Planning is a key role within the GPS organization in the Case Evaluation and Reporting (CER) area and will be responsible for developing and maintaining a Center of Excellence (CoE) for aggregate reporting and risk management planning.
As part of GPS team, the Director will collaborate across GPS and the broader organization including regulatory affairs, clinical operations, and medical affairs to drive strategic planning and project management of safety reporting results across the Regeneron portfolio. You will ensure quality and compliance/metrics through the development and maintenance of scheduling reporting activities, kick-off meetings for aggregate reports, risk management plans, Health Authority Responses and tracking/management of achievements
In this role, a typical day might include the following:
Responsible for oversight of activities related to aggregate reporting (PSUR/PBUR, DSUR, SUSAR/SARs, PAER), Risk Management Plans, HA responses, CAPAs, audits/inspections and other PV results
Maintenance of Aggregate Report Calendar, RMP Tracker, RMM List and HA Response Tracker
Ensure efficient and robust procedures to drive quality, timeliness and compliance with regulations
Coordinate and maintain dashboards around organizational compliance, performance and quality and serves as a key partner to GPS's Quality Compliance and Business Support team
Supervise for resource gaps or delays with PV result process and aggregate report project plans
Provide appropriate feedback to PV colleagues for process on aggregate reports to ensure quality
We need the implementation of and supervision of key performance indicator (KPIs) results
Provide oversight of outsourcing vendors as applicable
Collaborate with internal and external partners as well as TAL in the management of deliverables including all aggregate reports and risk management plans.
Ensure the tracking and management all key achievements
Ensure accurate and timely notification to Teams for all reports
Ensure cross-functional assignment of all activities related to results
Proactively follow up with Action Owners and Contributors
Liaise with other functions to ensure information is forwarded in a timely fashion
This role might be for you if:
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