AI-Driven Pharmacovigilance Data Analytics Lead

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Annual bonus

Share options

Pension scheme with company matching

Private medical insurance

Education assistance

Wellness program

Collaborative environment

Job summary

Grifols seeks a Pharmacovigilance expert to lead data analysis for safety reports, signals and ad hoc requests. You will support PV systems, test changes with regulators and drive cost-efficient solutions while ensuring regulatory compliance.

You will manage PV documentation, collaborate with IT on PV projects, and promote adoption of new processes and AI-powered tools across the safety teams in Ireland and beyond.

Qualifications

• Bachelor’s degree in Health Sciences or Bioscience.
• Experience in pharmacovigilance and PV databases.
• Knowledge of Good Pharmacovigilance Practices and regulations.
• Proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
• Familiarity with reporting tools such as Business Objects.
• Knowledge of E2b (R2) and E2b (R3) terminology; MedDRA.
• Fluent in Spanish and English.
• Strong writing and communication skills.
• Self-starter with attention to detail.

Responsibilities

• Lead and coordinate safety data analysis for aggregate reports, signals, and ad hoc requests.
• Support drug safety systems with administration tasks, including configuration updates and testing with regulators.
• Serve as a subject matter expert delivering cost-effective, sustainable PV solutions.
• Manage documentation for PV systems and applications, including SOPs, WPs, user requirements, specs and process diagrams.
• Drive change management to ensure adoption of new processes and integration of new applications within PV.
• Collect, prioritize and plan system improvements based on user feedback while ensuring regulatory compliance.
• Act as the primary PV contact for IT-related PV projects.
• Drive Innovation through AI in Pharmacovigilance to improve signal detection, case processing and compliance.

Skills

Pharmacovigilance

Data analysis

PV databases management

Good Pharmacovigilance Practices

MS Office

Power BI

R

Spanish language

English language

Technical writing

Education

Bachelor’s degree in Health Sciences

Bioscience degree

Tools

Business Objects

MedDRA

E2b (R2)

E2b (R3)

Job description

Grifols seeks a Pharmacovigilance expert to lead data analysis for safety reports, signals and ad hoc requests. You will support PV systems, test changes with regulators and drive cost-efficient solutions while ensuring regulatory compliance.

You will manage PV documentation, collaborate with IT on PV projects, and promote adoption of new processes and AI-powered tools across the safety teams in Ireland and beyond.