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.
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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.
Salary Range (annually)$134,400.00 - $219,200.00
