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.
Mission
Provides operational support for global Pharmacovigilance (PV) activities for Grifols investigational and marketed products. Ensures Drug Safety, Pharmacovigilance deliverables are of the highest quality and meet general Regulatory Reporting timelines. Responsible for Safety Data Analysis, Data Review, and management of the integrated Safety Database utilized by worldwide Grifols pharmacovigilance personnel.
What your responsibilities will be
To participate in the safety data collection, review, processing, evaluation, analysis and compilation:
Participate in the extraction,
review and analysis of information from the pharmacovigilance database, performing Safety Information Analytics, Safety Data Analysis, Data Extraction, Data Review, and Data Management.
Compilation and reconciliation of information in order to prepare documentation required by pharmacovigilance legislation:
Process and review safety data to develop Aggregate Safety Reports.
Support responses to requests from regulatory agencies, ensuring Regulatory Compliance.
Coordinate and manage creation of SQL queries for Data Extraction used in different PV documents.
Develop training documentation and/or work instructions to determine methods and procedures.
Work as Signal Analyst during Signal Detection and Signal Management activities, including extraction of signal detection reports and ensuring document filing and archiving.
Ensure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities:
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📌 TECHNICAL DRUG SAFETY OFFICER (España)
🏢 Grifols
📍 España
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