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. 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 comply with regulatory PV requirements.
A typical day might include the following:
Collaborate with subject matter experts within and outside the GPS department to develop, implement and maintain: robust processes (SOPs, WIs, BPTs and Policies) for regulated pharmacovigilance activities consistent with global regulatory requirements, industry and Regeneron corporate standards
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
Lead, or participate in, as requested, initiatives to continuously enhance the effectiveness and efficiency of GPS processes by gathering, analyzing and presenting relevant metrics on the performance of the processes
Partner with GD Quality, GPS Quality and Compliance and other relevant GPS lines to manage quality events and CAPAs for GPS Standards and Training. Provide support to other GPS functions as needed to address process-related quality events/CAPAs.
Partner with Regeneron SMEs, GD Quality, GPS Quality and Compliance and other stakeholders to investigate non-compliance with procedures and support CAPA completion
In collaboration with GD Training, Regulatory Affairs Business Operations, and HR Technology, provide regular metrics on GPS training compliance
Ensure inspection-readiness of all procedures and training records at all times to support GPS audits and health authority inspections
This role might be for you if you have:
Experience with Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems
Track record of successful project management relevant to quality management
Strong organizational skills
Ability to write procedural documents to accepted standards of quality
To be considered for this opportunity, you must have at minimum a Bachelor's degree and 7+ years of Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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