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Manager, Global Patient Safety Systems

unlimited holidays - extra holidays - extra parental leave

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United States

Offer summary

Qualifications:

5 years of pharmacovigilance experience, 3-4 years in safety reporting, 1 year of visualization/BI tool experience, Knowledge of FDA, EU, ICH regulations, In-depth knowledge of safety databases and reporting tools.

Key responsabilities:

Oversee daily activities for safety data requests
Review and document user requirements and testing reports
Execute Operational Qualification test scripts
Collaborate with GDS/IT for system support
Assist with training and troubleshooting for users

Regeneron Biotech: Biology + Technology Large https://www.regeneron.com/

5001 - 10000 Employees

See more Regeneron offers

Job description

This position is to support the Global Patient Safety 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, 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 systems validation documentation, and performing support of automation or reporting platform(s) change controls, represent GPS Systems team in project. The position may be called upon to assist with training end users on reporting or analytic updates, and troubleshooting user-reported issues.

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
Troubleshooting user-reported issues of diverse scope
Liaising closely with the Global Development Solutions (GDS) / IT team and managed service team, in support and maintenance of GPS systems
Contributing to and review user requirements for new GPS System projects; contributing and reviewing project-related computer systems validation documentation
Executing Operational Qualification/Performance Qualification test scripts, in support of safety systems change controls, and in accordance with Good Documentation Practices
Generating database searches and output in support of ad-hoc requests for safety data
As needed, assisting in providing end user training on safety system related updates to internal GPS staff and external vendors consuming report
Contributing to the production of system specific metrics and monitoring
Collaborating with GDS on continuous improvement opportunities for systems, reports, and other end-users focused solutions
Executing project specific deliverables for reporting and/or analytic products
Serving as subject-matter expert and steward for delivered reporting, analytic or other delivered solution(s)
Providing 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 safety database (Argus preferred)
In-depth knowledge for reporting/business intelligence/visualization tools eg. Qlik, OBIEE, Tableau, PowerBI, etc.
In-depth knowledge of generating advanced database searches and developing reporting output
In-depth knowledge working with case intake systems preferred
Good knowledge of PV periodic reporting (eg. DSUR, PBRER, etc.)
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)
Working knowledge with automation and/or analytic environments (eg. R, SAS, Databricks)
Working knowledge with advanced analytic methodologies
In-depth experience working within 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 5years of PV experience including 3-4 years safety reporting experience including periodic reporting (DSUR, PBRER, etc.). 1 year of visualization / business intelligence/ automation tool experience.

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.