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Regeneron Pharmaceuticals Sr Manager Global Patient Safety in Tarrytown, New York

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:

  • Extensive knowledge of US, ICH and EU PV and GCP/GVP regulations

  • Strong project management skills

  • Excellent strategic decision-making and analytical skills;

  • Excellent decision making and judgment.

  • Strong communications skills

  • Project management experience strongly preferred, PMP preferred

  • Experience with CA Inspections (PV and GCP);

  • Experience working with Alliance Partners

  • Medical writing experience with regulatory documentation

  • Minimum 5 + years of pharmacovigilance experience with focus on Aggregate Reporting and Risk management;

  • Bachelor’s Degree in Life Sciences preferred.

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