Pharmacovigilance Data Analysis Manager

Grifols

  • Sant Cugat del Vallès, Barcelona
  • Permanente
  • Tiempo completo
  • Hace 30 días
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: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.What your responsibilities will be
  • 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 smooth adoption of new processes and support the integration of new applications within the PV team.
  • Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
  • Act as the primary PV contact for IT-related PV projects.
  • Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.
Who you areTo 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.
  • 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 offerIt 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. If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!We look forward to receiving your application!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, please do not hesitate to inform us when applying. 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 packageContract of Employment: Permanent positionFlexibility for U Program: HybridLocation: Sant Cugat del Vallès (preferably) / Other locations as Los Angeles, Clayton or Dublin will be consideredLocation: SPAIN : España : Sant Cugat del Valles || EMEA : Irlanda : Dublin || NORTH AMERICA : EE.UU. : CA-Los Angeles || NORTH AMERICA : EE.UU. : NC-Clayton || NORTH AMERICA : EE.UU. : NC-RTP:[[cust_building]]

Grifols