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Senior Monitoring Manager
4 months ago
This position is to support the Global Patient Safety (GPS) department in business support of safety systems utilized for pharmacovigilance. This includes overseeing daily activities such as generating searches and output in support of departmental data requests, internal audits, and health authority inspections. impact assessments and testing reports before releasing to a production state. It also includes project-specific responsibilities, such as contributing to and reviewing user requirements for new GPS systems, contributing to computer system validation documentation, and performing support of reporting platform(s) change controls, and represent the GPS Systems team in projects. The position may be called upon to assist with training end users on reporting or analytic updates, and troubleshooting user-reported issues. document, perform and test reporting updates in the safety systems testing environments
Contribute to and review user requirements for new GPS System projects; contribute and review project-related computer systems validation documentation
Execute Operational Qualification/Performance Qualification test scripts, in support of safety system change controls, and in accordance with Good Documentation Practices
Generate database searches and output in support of ad-hoc requests for safety data
Assist in providing end user training on safety system related updates to internal GPS staff and external vendors consuming report
Contribute to the production of system specific metrics and monitoring
Execute project specific deliverables for reporting and/or analytic products
Strong knowledge of Argus safety database structure and working knowledge of Argus configuration (product, license, study and reporting)
Strong knowledge for reporting/business intelligence/visualization tools (eg. Qlik, OBIEE, Tableau, PowerBI, etc.)
utilizing SQL directly or through existing platforms
R, SAS, Databricks)
Familiarity with concepts of safety surveillance (aka signaling)
In-depth experience working withing project teams (leader project teams and/or direct reports preferred)
Ability to communicate with senior leaders
7 years of PV experience including 4-5 years safety reporting experience including periodic reporting (DSUR, PBRER, etc.).
~2 years visualization / business intelligence tool experience
#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 which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.
