Pharmacovigilance Data Analysis Manager

Grifols; Sant Cugat del Vallès; Híbrido; EUR 70.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible schedule

Hybrid work

Descripción de la vacante

Grifols is seeking a Pharmacovigilance Data Analysis Manager to lead global safety data initiatives across investigational and marketed products. You will ensure high-quality PV deliverables, support regulatory reporting timelines, and partner with IT to test and implement PV system changes in a compliant environment.

You will manage PV databases, oversee signal management, develop training materials, and coordinate with Regulatory Authorities.

Formación

• Bachelor-level degree in Health Sciences or Bioscience is required.
• 4+ years of pharmacovigilance experience including PV database management.
• Strong knowledge of Good Pharmacovigilance Practices and regulatory guidelines.

Responsabilidades

• Provide operational support for global pharmacovigilance activities.
• Manage PV databases and data extraction for reports and submissions.
• Lead PV system integration and change management efforts.

Conocimientos

Pharmacovigilance

Team management

MS Office

Communication skills

Analytical skills

Problem solving

Educación

Bachelor’s in Health Sciences or Bioscience

Herramientas

Power BI

Business Objects

R

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 in an excellent working environment.

Information about Grifols is available at www.grifols.com.

We believe in diverse talent and want to remove any barriers that may hinder your participation.

If you require any adjustments in our selection process, we are here to help.

Grifols is an equal opportunity employer.

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).

Benefits package

Contract of Employment: Permanent position

Flexibility for U Program: Hybrid

Location: Sant Cugat del Vallès

www.grifols.com

Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]