Senior Pharmacovigilance Data & AI Manager

Grifols; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Highly competitive salary

Annual performance-based bonus

Share options scheme

Group pension with company matching

Job summary

Grifols is seeking a Pharmacovigilance professional to lead analysis for aggregate reports, manage PV systems and drive improvements across IT interfaces and regulatory processes.

The role requires a strong PV background, experience with regulatory timelines, and proficiency in AI-enabled safety tools to enhance signal detection and case processing. Dublin-based, on-site with competitive benefits.

Qualifications

• Bachelor’s degree in Health Sciences or Bioscience.
• 4+ years of pharmacovigilance experience including database management.
• Knowledge of E2b R2/R3 and MedDRA is a plus.
• Proficient in Windows and MS Office; BI tools like Power BI preferred.
• Strong writing, communication and regulatory compliance skills.

Responsibilities

• Lead safety data analysis for aggregate reports and signal management.
• Manage PV systems documentation and IT-related PV projects.
• Coordinate changes and testing with IT and regulatory authorities.
• Drive process improvements and AI pilot initiatives in PV operations.

Skills

Pharmacovigilance experience

Good Pharmacovigilance Practices

Power BI

Bioinformatics/biostatistics

Windows/MS Office

Data analysis

SQL or database knowledge

Spanish (fluent)

GxP and regulatory knowledge

Education

Bachelor's degree in Health Sciences or Bioscience

Tools

Business Objects

Job description

Grifols is seeking a Pharmacovigilance professional to lead analysis for aggregate reports, manage PV systems and drive improvements across IT interfaces and regulatory processes.

The role requires a strong PV background, experience with regulatory timelines, and proficiency in AI-enabled safety tools to enhance signal detection and case processing. Dublin-based, on-site with competitive benefits.