Tarrytown, New York
Regeneron Pharmaceuticals, Inc.
This position is responsible for supporting the quality & compliance activities associated with Global Patient Safety. Such activities include developing, performing, trending and analyzing quality and compliance metrics and associated outputs related to ICSRs, Aggregate Reports and Benefit-Risk associated deliverables. This role will initially act as an individual contributor, reporting into the head of GPS Quality and Compliance (Q&C) and may evolve into people management.
Develop and execute a compliance and quality oversight governance for Global Patient Safety benefit-risk deliverables including, but not limited to, Risk Management Plans, Signal Detection, and Safety Variations
Liaise with GPS subject matter experts, Regulatory Affairs, and other key functions to proactively identify potential trends or significant non-compliance
Support Global Patient Safety-related non-compliance including the investigation, trending, and requesting supporting documentation and evidence of CAPA implementation based on established documented procedures
Conduct regular and timely review and compilation of quality and compliance outputs based on established documented procedures
Collaborate with key stakeholders to support audits and inspections as related to GPS Quality & Compliance activities
Effectively manage workload to independently ensure overall compliance with standards and timelines
Work effectively with other Global Patient Safety sub-functions, Contract Research Organization, Vendors, and relevant personnel to discuss issues and identify timely solutions
As needed, assist in review and contribution to Global Patient Safety Quality and Compliance-related SOPs, Work Instructions and Job Aids
Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly
Good communication skills, both written and verbal.
Ability to multi-task and effectively manage demanding timelines
Ability to work collaboratively across functions and roles
High level of accountability; drive results
Strong understanding of global safety reporting regulations and guidelines including FDA, ICH, and GVP
Strong computer skills and experience working with the Microsoft programs (Word, Excel, PowerPoint, Outlook)
Knowledge of medical concepts and terminology
Familiarity with data analytics platforms
Strong knowledge of safety database
Expertise in benefit-risk management preferred
Minimum 10 years pharmacovigilance experience
Healthcare Professional preferred