Senior Manager, Global Patient Safety Reporting and Analytics - Regeneron Pharmaceuticals, Inc.

Overview:

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. Additionally, reviewing user requirements for reporting requests (operational and periodic reports such as DSUR, PBRER, etc.), 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. This position reports to the Director, GPS Systems, for general supervision.

In this role, a typical day might include:

• Collaborating with GPS end users to develop reporting requirements; document, perform and test reporting updates in the safety systems testing environments

• Troubleshoot user-reported issues of diverse scope

• Liaise closely with the Global Development Solutions (GDS) / IT team and managed service team, in support and maintenance of GPS systems

• 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

• Collaborate with GDS on continuous improvement opportunities for systems, reports, and other end-users focused solutions

• Execute project specific deliverables for reporting and/or analytic products

• Serve as subject-matter expert and steward for delivered reporting, analytic or other delivered solution(s)

• Provide oversight to external support and/or development teams as needed

• As needed, serve as SME / GPS Systems lead for pre-inspection requests and provide on-site support during audit/inspection

This role might be for you if can/have:

• 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.)

• In-depth knowledge of generating advanced searches and developing output; utilizing SQL directly or through existing platforms

• In-depth knowledge of PV periodic reporting (eg. DSUR, PBRER, etc.)

• Working knowledge with case intake systems and case processing

• Working knowledge with analytic environments (eg. R, SAS, Databricks)

• Working knowledge with advanced analytic methodologies

• Working knowledge of relevant FDA, EU and ICH (International Conference on Harmonization) regulations governing clinical and post-marketing pharmacovigilance activities

• Familiarity with concepts of safety surveillance (aka signaling)

• In-depth experience working withing project teams (leader project teams and/or direct reports preferred)

• Strong written and verbal communication skills, required for frequent communication with both internal and external contacts

• Ability to communicate with senior leaders

• Proven ability to prioritize daily tasks independently and provide guidance for other team members in daily prioritization as needed

• Ability to ideate through solutions with business end-users and technical team members

To be considered you must have at least a Bachelor's degree in a related field as well as 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.

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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.

Salary Range (annually)