Would you like to join an international team working to improve the future of healthcare? 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. Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma‐derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people.

That's why we need a Pharmacovigilance Data Analysis Manager like you. Provides operational support for global pharmacovigilance activities for Grifols investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines.

Responsible for project implementation and execution of system, including responsibilities for providing safety ongoing business support and ongoing improvements. Key interface with the IT system administrators to verify and test system changes ensuring that the system is compliant and meets business needs. Support drug safety applications with business administration tasks Key expert to deliver solutions that are cost effective, sustainable, and meet business requirements Develop training documentation and/or work instructions to determine methods and procedures Coordination and management of signal management Management of documentation describing PV applications use, which may include, but not limited to: SOPs, WP, User requirements, functional and/or technical specifications, process flow diagrams Lead change management actions to assure PV team smoothly adapts to the new processes, as well as supporting the integration of a new application Interact with Regulatory Authorities as it relates to safety database data transmission Gathering, prioritizing,



and planning improvements based on user requests, considering overall regulations to the business Ensure data consistency and integrity within the safety database Management and coordination of the updates in the database configuration of submission rules to Regulatory Authorities Management and coordination of the updates in the database configuration of products and studies Supervision and management of queries for data extraction used in different PV documents Supervision and management of queries into the database to identify the interval and cumulative cases to be included in periodic reports Supervision and management for obtaining case listings from the database for specific situations Supervision and management of IT tickets needed for system compliance and improvements Planning and prioritizing scheduled IT tickets Project lead on the integration and establishment of the Grifols PV system You have a bachelor's 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 (such as R or Power BI). You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.

Experience in team management. You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration. You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).

Familiarity with reporting tools such as Business Objects is strongly preferred. You speak fluent Spanish and English. You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same versátil start time).

Contract of Employment: Permanent position Hybrid Type: Indefinido tiempo completo

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