Pharmacovigilance Data Analytics Lead

Grifols Shared Services North America, Inc; Ireland; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Salary

Bonus

Share options

Pension

Medical insurance

Career development

Education assistance

Wellness programs

Team environment

Job summary

Grifols is seeking an experienced Pharmacovigilance professional to oversee safety data analysis, system administration and regulatory reporting, ensuring high-quality deliverables. You will partner with IT, QA and regulatory teams to implement improvements.

The role requires 4+ years in pharmacovigilance, strong writing and communication skills, and expertise with PV databases, regulatory guidelines, and reporting tools. Fluency in English and Spanish is required.

Qualifications

• Bachelor's degree in Health Sciences or Bioscience with relevant training.
• At least 4 years of pharmacovigilance experience including database management.
• Knowledge of Good Pharmacovigilance Practices and regulatory guidelines.

Responsibilities

• Lead and coordinate safety data analysis for aggregate reports and signal management.
• Support PV systems with admin tasks including configuration updates and testing with authorities.
• Manage PV documentation: SOPs, WPs, requirements, specifications and process flow diagrams.
• Drive change management and adoption of new PV processes and applications.

Skills

Pharmacovigilance experience

GVP knowledge

MS Office

Languages: English & Spanish

Technical writing

Analytical skills

Communication & collaboration

Prioritization & organization

Education

Bachelor's in Health Sciences

Bioscience degree

Tools

Business Objects

Power BI

R (bioinformatics)

MedDRA/WhoDrug knowledge

Job description

Grifols is seeking an experienced Pharmacovigilance professional to oversee safety data analysis, system administration and regulatory reporting, ensuring high-quality deliverables. You will partner with IT, QA and regulatory teams to implement improvements.

The role requires 4+ years in pharmacovigilance, strong writing and communication skills, and expertise with PV databases, regulatory guidelines, and reporting tools. Fluency in English and Spanish is required.