Regeneron's Patient Safety organization is seeking a Senior Manager, Aggregate Reporting Management to join our team!

In this role, a typical day might include:

This position in the Global Patient Safety (GPS) Operations is responsible for management of aggregate safety reporting activities across all phases of the product lifecycle. This role supports the consistent, compliant, and scientifically robust preparation, distribution and submission of periodic and ad-hoc safety reports to health authorities, collaborators and contract research organizations worldwide.

This role might be for you if you can/have:

• Drives preparation, development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs) Deliverables
• Leads Aggregate Report planning, production and distribution activities across GPS and other functions across US, EU, Japan and other ICH regions, as well as non-ICH regions
• Provides expertise and guidance to authors and contributors of aggregate reports
• Maintains compliance metrics and contributes to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance
• Implements effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality
• Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases
• Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports
• Acts as subject matter expert during audits and inspection.
• Provides oversight, and training as needed of CRO respective activities in support of high quality and timely aggregate reports
• Acts as a functional vendor management overseeing and driving high quality outputs from our vendors
• Develops and maintains aggregate report procedural package (SOPs, Work Instructions), reports' templates, KPIs
• Drives process improvement through automation and other tech initiatives.

To be considered for this opportunity, you must have the following:

• Bachelor's degree required (advanced degree or HCP-focused background preferred) and 5+ years of Pharmacovigilance experience, with a demonstrated focus on Aggregate Safety Reporting.
• Project management experience strongly preferred, PMP preferred
• Experience with health authority inspections (PV and GCP)
• Medical writing experience with regulatory documentation
• Strong project management skills
• Excellent strategic decision-making and analytical skills
• Strong communication and writing skills
• Strong understanding of Scientific content
• Proven experience with technology implementations allowing for streamlined process execution.

#GDPSJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.

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.

Salary Range (annually)

$134,400.00 - $219,200.00