R Data Analysis Tools Engineer For Hpc (Flexible Hours)

Barcelona Supercomputing Center; Barcelona; Híbrido; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

Grifols seeks an experienced Pharmacovigilance Data Analysis Manager to lead global PV activities and ensure high-quality safety deliverables meeting regulatory timelines.

You will interface with IT, coordinate signal management, and oversee PV data administration, ensuring data integrity across safety databases while collaborating with authorities and internal teams.

Formación

• Bachelor’s degree in Health Sciences or Bioscience.
• At least 4 years in pharmacovigilance including database management.
• Proven knowledge of Good Pharmacovigilance Practices and regulatory guidelines.
• Proficient in Windows and MS Office; BI tools experience.
• Fluent in Spanish and English.

Responsabilidades

• Provide operational support for global pharmacovigilance activities.
• Lead PV system integration projects and ensure regulatory timelines.
• Manage documentation: SOPs, requirements, specs, process diagrams.
• Coordinate data extraction for PV documents and reporting.
• Interact with Regulatory Authorities for safety data transmission.

Conocimientos

Pharmacovigilance

Team management

Data analysis tools

Windows/MS Office

E2B familiarity

Spanish & English

Educación

Bachelor’s degree Health Sciences/Bioscience

Herramientas

Power BI

Business Objects

Descripción del empleo

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.
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.
_Role Mission_ : 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.
What your responsibilities will be
+ 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
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ 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 have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
+ You speak fluent Spanish and English.
+ You are proven self-starter with strong work ethic and the ability to exercise good judgment.
+ You must be proactive, results oriented and have 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.
+ 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.
+ Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines.
What we offer
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers