Associate Director, GPS Analytics, Scientific Enablement
The Associate Director Analytics, Scientific Enablement is responsible for ensuring that all safety data can be retrieved and displayed for analysis, report development and decision making. Support the development and production of analyses of safety data from various data sources.
In this role, a typical day might include the following:
Technical lead and SMEfor Analytics in Global Patient Safety.
Collaborate with internal partners and vendor developing business requirements, validation and documentation.
Collaborates proactively with study teams, cross-functional team members, external business partners and vendors. Collaborate with Case Evaluation and Reporting Management (CERM), PV Planning and Therapeutic Areas to ensure Safety Systems are in compliance based on changing regulations and business needs, including implementation of reporting rules, products, studies, code lists, users/security, dictionary updates (MedDRA/WHO), and configuration of E2B reporting for gateway submissions.
Provide support and education on Safety & Signaling Systems to end users and sponsors.
Develop SOP's relevant to the use and maintenance of reports and Analytics to ensure inspection readiness.
Maintain traceable documentation of analyses.
Programming of sophisticated queries and reports in relational database and analytical systems using PL/SQL, Cognos, Business Objects, OBIEE, SAS, Tableau, Toad or Spotfire.
Responsible for oversight of the generation of formal reports, summaries and listings in support of medical monitoring, signal detection, and aggregate reporting deliverables (DSUR, PBRER, 6-Monthlies).
Collaborate on database adherence to SDLC, SOPs, GxP, ICH, FDA regulations, EU Annex 11 and 21 CFR Part 11 compliance
This role might be for you if:
- Safety Systems administration, gateway support, data collection, report generation.
- Extensive knowledge of Argus, Arisg Safety Databases
- Knowledge of Signaling tools (eg. Empirica, Spotfire)
- Regulatory Inspection readiness
- Established skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPI's & QPI's
- Established skills in relational database technology and query (SQL) development.
- Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
- Strong planning, organization, written and oral communication skills
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.