Manager, Global Patient Safety Systems

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 emp