Regeneron is seeking a Manager, Global Patient Safety Quality and Compliance role, reporting into the Associate Director of Quality and Compliance (Q&C). This position is responsible for performing quality review tasks related to ICSRs and other GPS deliverables including conducting quality control review of individual case safety reports. This position will also provide support in other tasks for Q&C, as needed.
In this role, a typical day might include:
Conducting regular quality control review of ICSRs based on established documented procedures
Conducting quality control reviews of Global Patient Safety deliverables including Safety Agreements and Safety Management Plans
Generating and reviewing metrics related to quality control of ICSRs
Performs regular trending of quality results to identify potential trends
This role might be for you if can:
Effectively manage workload to ensure overall compliance with GPS standards and timelines
Work effectively with other GPS sub-functions and relevant personnel to support GPS quality issues and identify timely solutions
Support audits and inspections related to GPS as needed
As needed, assist in review and contribution to GPS Quality and Compliance-related documented procedures
Support deliverables as needed for GPS Quality & Compliance
Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly.
To be considered for this opportunity, you must have the following:
Minimum Bachelor's Degree with 5+ years pharmacovigilance experience including case processing experience, health-care professional preferred
Effective and clear communication skills, both written and verbal.
Ability to effectively manage demanding timelines
Ability to work collaboratively across functions and roles High level of accountability; drive results
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, Teams)
Knowledge of medical concepts and terminology Strong knowledge of safety database (Argus preferred)
#GDPSJobs
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.
United States
