Senior Pharmacovigilance Data & AI Solutions Lead

Grifols, S.A; Dublin; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Highly competitive salary

Annual performance bonus

Private medical insurance

Pension scheme with company matching

Job summary

Grifols, S.A. in Ireland seeks an experienced Pharmacovigilance professional to manage safety data analysis, PV systems, and regulatory reporting. You will act as the PV liaison with IT, drive AI-enabled improvements, and ensure compliant, timely deliverables.

The role requires 4+ years in PV, knowledge of GVP, E2b, MedDRA, and strong MS Office skills. Fluency in English and Spanish is expected; Irish work authorization preferred.

Qualifications

• Bachelor’s degree in Health Sciences or Bioscience; bioinformatics/biostatistics or data analysis tools (R/Power BI) beneficial.
• 4+ years of pharmacovigilance experience with PV databases.
• Knowledge of Good Pharmacovigilance Practices and safety data administration.
• Proficient in Windows and MS Office; familiarity with reporting tools preferred.
• Knowledge of E2b (R2/R3) and medical terminology (MedDRA) a plus.
• Fluent in English and Spanish.

Responsibilities

• Lead and coordinate safety data analysis for aggregate reports and signal management.
• Support drug safety systems through administration tasks and testing with regulatory authorities.
• Deliver and evaluate cost-effective, sustainable PV solutions meeting business requirements.
• Manage PV documentation: SOPs, WPs, user requirements, specs, process diagrams.
• Drive change management and integrate new applications within the PV team.
• Plan system improvements based on user feedback while ensuring regulatory compliance.
• Act as PV contact for IT-related PV projects.
• Drive AI innovations in pharmacovigilance to improve signal detection and data analysis.

Skills

PV systems knowledge

GVP & regulations

MS Office proficiency

Technical writing

Analytical skills

Interpersonal skills

Self-starter

Problem solving

Prioritization

Education

Bachelor’s degree in Health Sciences or Bioscience

Tools

Business Objects

Job description

Grifols, S.A. in Ireland seeks an experienced Pharmacovigilance professional to manage safety data analysis, PV systems, and regulatory reporting. You will act as the PV liaison with IT, drive AI-enabled improvements, and ensure compliant, timely deliverables.

The role requires 4+ years in PV, knowledge of GVP, E2b, MedDRA, and strong MS Office skills. Fluency in English and Spanish is expected; Irish work authorization preferred.