Sobre el puesto
OverviewIn this role you will support global pharmacovigilance activities for Grifols products, ensuring high-quality safety deliverables and timely regulatory reporting.
You will lead system projects, provide safety business support, and work with IT to keep the PV platform compliant.
You will drive improvements, manage PV applications, and coordinate data-related activities across teams.
This position offers a chance to shape the safety data ecosystem at a world-leading pharma company.
Compensaciones / BeneficiosBenefits package
Permanent contract
Hybrid work option
Flexible schedule
Location: Sant Cugat del Vallès
Support for diverse talent and adjustments in selection process
ResponsabilidadesSupport drug safety applications with business administration tasks
Deliver cost-effective PV solutions that meet business requirements
Develop training materials and work instructions
Coordinate and manage signal management
Manage PV documentation (SOPs, WP, requirements, specs)
Lead change management for new processes and applications
Interface with Regulatory Authorities on safety data transmission
Prioritize and plan improvements based on user requests and regulations
Ensure data consistency and integrity in the safety database
Manage updates to submission rules and product/study configurations
Oversee data extraction queries for PV documents
Oversee queries to identify case intervals and counts for reports
Coordinate IT tickets for system compliance and improvements
Plan and prioritize scheduled IT tickets
Lead projects to integrate and establish the Grifols PV system
Requisitos principalesBachelor in Health Sciences or Bioscience
Experience in pharmacovigilance (min 4 years) including PV databases
Team management experience
Knowledge of GMP PV practices and safety-data administration
Proficiency in Windows and MS Office
Familiarity with reporting tools (e.g., Business Objects)
Knowledge of E2b (R2/R3) and medical terminology (MedDRA, WhoDrug a plus)
Fluent in Spanish and English
Strong self-start, judgment, and attention to detail
Strong organizational, analytical, problem-solving, and communication skills
Ability to prioritize and manage multiple tasks
proactive
results-oriented
team player
Business Objects
Power BI
R