Descripción de la vacante
Grifols
20k
Spain, Sant Cugat
Pharmacovigilance Data Analysis Manager en Sant Cugat, España is listed on Jobeax. Browse 80,000+ vacancies available.
https://jobeax.com/link/cDiGuuHDsd2wdEj5 { max-width: 1020px;}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 https://jobeax.com/link/6ssAMCCM8qWJAJzf 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 https://jobeax.com/link/inTxs1j5RJwFtMZA 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 https://jobeax.com/link/9f2c0FHneDJWUtOn 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 https://jobeax.com/link/VjPQTEyNtSHhhqOP your responsibilities will be Support drug safety applications with business administration tasksKey expert to deliver solutions that are cost effective, sustainable, and meet business requirementsDevelop training documentation and/or work instructions to determine methods and proceduresCoordination and management of signal managementManagement of documentation describing PV applications use, which may include, but not limited to: SOPs, WP, User requirements, functional and/or technical specifications, process flow diagramsLead change management actions to assure PV team smoothly adapts to the new processes, as well as supporting the integration of a new applicationInteract with Regulatory Authorities as it relates to safety database data transmissionGathering, prioritizing, and planning improvements based on user requests, considering overall regulations to the businessEnsure data consistency and integrity within the safety databaseManagement and coordination of the updates in the database configuration of submission rules to Regulatory AuthoritiesManagement and coordination of the updates in the database configuration of products and studiesSupervision and management of queries for data extraction used in different PV documentsSupervision and management of queries into the database to identify the interval and cumulative cases to be included in periodic reportsSupervision and management for obtaining case listings from the database for specific situationsSupervision and management of IT tickets needed for system compliance and improvementsPlanning and prioritizing scheduled IT ticketsProject lead on the integration and establishment of the Grifols PV systemWho 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 https://jobeax.com/link/8ugrpZQN7XAOFxi1 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 https://jobeax.com/link/x2cBc6vM6YtteRXw in team https://jobeax.com/link/cxdlgINMp2L6Fnrv have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data https://jobeax.com/link/uykNORwZ908lq80y are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).Familiarity with reporting tools such as Business Objects is strongly https://jobeax.com/link/iDshVdTCtyKtfFUF have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a https://jobeax.com/link/MZDP14G6NIPUnKmI speak fluent Spanish and https://jobeax.com/link/7Cn6txxP4ECJ34zd are proven self-starter with strong work ethic and the ability to exercise good https://jobeax.com/link/zIRM6z2IEW7k9UeF must be proactive, results oriented and have strong attention to https://jobeax.com/link/RPTf7ZRzWkiuPeQL organizational, analytical and problem-solving skills with the ability to make structured decisions on a routine https://jobeax.com/link/7SmXkQhGHoxpcLSp interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team https://jobeax.com/link/gD6KwWWDdaH9sykX possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective https://jobeax.com/link/1FNt7OoOsnmriVq3 to effectively prioritize and manage multiple tasks to ensure successful completion targeted https://jobeax.com/link/SYbSsJQwcIYwNzJs 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 https://jobeax.com/link/p5XUed4s0537eTqI about Grifols is available at . 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 https://jobeax.com/link/YvhwNejADGXVlrWy is an equal opportunity https://jobeax.com/link/rJDNatsnPaP8fGup 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 VallèsLocation: SPAIN : España : Sant Cugat del Valles:[[cust_building]]Learn more about Grifols
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