Experteer Overview
In 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 / Incentivos
• Support 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

Responsabilidades
• Bachelor 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

Requisitos principales
• Benefits package
• Permanent contract
• Hybrid work option
• Flexible schedule
• Location: Sant Cugat del Vallès
• Support for diverse talent and adjustments in selection process

📌 Pharmacovigilance Data Analysis Manager (San Cugat del Vallés)
🏢 Grifols
📍 San Cugat del Vallés