Pharmacovigilance Data Analytics Lead

Ndt Global; Barcelona; Híbrido; EUR 70.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work schedule

Benefits package

Descripción de la vacante

Grifols, a leading global healthcare company, is seeking a Pharmacovigilance Data Analysis Manager to provide operational support for global PV activities. You will ensure high-quality safety deliverables, oversee system changes, and coordinate with IT and Regulatory Bodies to maintain compliance.

Role emphasizes PV application administration, data integrity, and continuous improvements across global pharmacovigilance processes within a hybrid work setting in Sant Cugat del Vallès.

Formación

• Bachelor's in Health Sciences or Bioscience; bioinformatics/biostatistics training encouraged.
• At least 4 years of pharmacovigilance experience with PV databases.
• Experience in team management and regulatory liaison.
• Knowledge of Good Pharmacovigilance Practices and safety data handling.
• Proficient with Windows and MS Office; familiarity with reporting tools.

Responsabilidades

• Support drug safety applications with business administration tasks.
• Deliver cost-effective PV solutions meeting business requirements.
• Develop training documentation and work instructions.
• Coordinate and manage signal management activities.
• Lead change management for new PV processes and applications.
• Interact with Regulatory Authorities on safety data transmission.
• Gather, prioritize, and plan improvements considering regulatory needs.
• Plan and coordinate updates in safety database configurations.
• Lead integration and establishment of the Grifols PV system.

Conocimientos

Pharmacovigilance

Team management

Good Pharmacovigilance Practices

MS Office

Business Objects

R

MedDRA/WhoDrug knowledge

Spanish fluency

English fluency

Technical writing

Educación

Bachelor's in Health Sciences or Bioscience

Herramientas

Power BI

Business Objects

R

Descripción del empleo

Grifols, a leading global healthcare company, is seeking a Pharmacovigilance Data Analysis Manager to provide operational support for global PV activities. You will ensure high-quality safety deliverables, oversee system changes, and coordinate with IT and Regulatory Bodies to maintain compliance.

Role emphasizes PV application administration, data integrity, and continuous improvements across global pharmacovigilance processes within a hybrid work setting in Sant Cugat del Vallès.