22 ago
|
Grifols
|
San Cugat del Vallés
22 ago
Grifols
San Cugat del Vallés
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.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Position Summary
The employee occupying this position will perform activities in accordance with the Pharmacovigilance System Master File (PSMF), Standard Operating Procedures (SOPs), Working Practices (WPs), and applicable pharmacovigilance legislation.
Ensures that pharmacovigilance deliverables are of the highest quality and meet integral regulatory reporting timelines. Responsible for project implementation and execution of systems,
including providing ongoing safety business support and continuous improvements. Acts as a key interface with IT system administrators to validate and test system changes, ensuring the system remains compliant and meets business requirements.
What You'll Do:
- 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
📌 Pharmacovigilance Data Analysis Manager (San Cugat del Vallés)
🏢 Grifols
📍 San Cugat del Vallés