Pharmacovigilance Data Analysis Manager

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.

Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high‑quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.

• Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad‑hoc requests.
• Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
• Serve as a subject matter expert in delivering and evaluating cost‑effective, sustainable solutions that meet business requirements.
• Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/technical specifications and process flow diagrams.
• Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
• Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
• Act as the primary PV contact for IT‑related PV projects.
• Drive Innovation through AI in Pharmacovigilance:
  Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI‑driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross‑functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.

• University degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc.) or Bioscience (biochemistry, biotechnology, biology, etc.). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (e.g., R or Power BI).
• At least 4 years of pharmacovigilance experience including management of pharmacovigilance databases.
• Proven knowledge of Good Pharmacovigilance Practices; current legislation, regulations, guidelines, medical coding and safety‑data administration.
• Proficiency in Windows and MS Office (Excel, PowerPoint, Visio, Word).
• Familiarity with reporting tools such as Business Objects is strongly preferred.
• Knowledge of E2b (R2) and E2b (R3) and basic familiarity with medical terminology, MedDRA, WHODrug are a plus.
• Fluent in Spanish and English.
• Proven self‑starter with strong work ethic, good judgment, proactive, results‑oriented and strong attention to detail.
• Strong organizational, analytical and problem‑solving skills with the ability to make structured decisions on a routine basis.
• Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
• Strong technical writing and communication skills with the ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
• Ability to effectively prioritize and…