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Associate Director, Global Patient Safety
2 months ago
Reporting to the Head of GPS (Global Patient Safety) Standards Training & Intelligence, this position is responsible for establishing and maintaining procedures and policies consistent with global regulatory requirements and industry standards; and assuring training on those procedures and policies is conducted, throughout the GPS department and globally.
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The responsibilities of this job are foundational in the creation and maintenance of the Pharmacovigilance (PV) Quality Management System that is essential in enabling the department to align with regulatory PV requirements in all relevant territories worldwide, and to operate efficiently and effectively in alignment with established industry practices.
This position serves as a central interface for GPS with partnering functions such as Industrial Operations and Product Supply Quality Assurance (Complaints), Legal, Procurement, and Commercial.
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- Communications, guidance and supplementary training materials/support to complement the processes
- Supply a training program for all individuals within the patient safety department, and outside the department if they are involved in a regulated GVP activity
- Responsible, in partnership with GPS and other business area subject matter experts, to: review all procedures periodically to ensure they continue to correctly describe the GPS activities followed and monitor compliance with required training, and address non-compliance by working with line management.
- Lead, or participate in, as requested, initiatives to continuously enhance the effectiveness and efficiency of GPS processes by gathering, analyzing and communicating relevant metrics on the performance of the processes
- Collaborated closely regularly with partners (e.g., GD Quality, GD Process & Procedures) on standards for procedures and related documents, and the management of deviations
- Partner with GD Quality, GPS Quality and Compliance and other relevant GPS lines to lead quality events and CAPAs for GPS Standards and Training. Provide support to other GPS functions as needed to address process-related quality events/CAPAs.
- Handle assignment of adverse event (AE) & product complaint (PC) training globally to vendors
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- Bachelorâs degree is required. Education in the life sciences is a strong plus.
- 8+ years of relevant experience.
- Proven experience in Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry
- Experience with Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems
- Track record of successful project management relevant to quality management
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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levelsRegeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.