Technical Drug Safety Officer

Detalles de la oferta

.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 opportunities that foster an inclusive environment.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 Technical Drug Safety Officer like you.MissionProvides 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 data reviews and management of the integrated database utilized by worldwide Grifols pharmacovigilance personnel.What your responsibilities will beTo participate in the safety data collection, review, processing, evaluation, analysis and compilationProcessing Grifols marketed products adverse event case reports (including definition of submissions required and conducting follow-up with reporters)Review of the weekly literature searchReview of the updates in pharmacovigilance legislationCompliance with archiving tasks for deliverables and relevant documentsCompilation of information for and participation in preparation of periodic safety update reportsSupport to the pharmacovigilance staff involved in audits and inspectionsProvide training to concerned personnel based on the training plan and managing training documentation and deliverables within relevant company departmentsSupport to the review and update of the SOPs, working practices or conventionsUse of queries for data extraction for different PV documentsEnsure data consistency and integrity within the safety databaseSupport to updates in the database configurationWho 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.Bachelor's degree in life scienceFluent written and spoken English (C1 Advanced) and Spanish. Having proficiency in additional languages such as Chinese, Italian, French, or others will be highly valuedExperience: 1 year as a trainee, or similar, in pharmaceutical industry or CRO working on quality, data entry or pharmacovigilance


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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