Technical Drug Safety Officer
hace 4 semanas
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.
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 data reviews and management of the integrated database utilized by worldwide Grifols pharmacovigilance personnel.
What your responsibilities will be
To participate in the safety data collection, review, processing, evaluation, analysis and compilation
Processing Grifols marketed products adverse event case reports (including definition of submissions required and conducting follow-up with reporters)
Review of the weekly literature search
Review of the updates in pharmacovigilance legislation
Compliance with archiving tasks for deliverables and relevant documents
Compilation of information for and participation in preparation of periodic safety update reports
Support to the pharmacovigilance staff involved in audits and inspections
Provide training to concerned personnel based on the training plan and managing training documentation and deliverables within relevant company departments
Support to the review and update of the SOPs, working practices or conventions
Use of queries for data extraction for different PV documents
Ensure data consistency and integrity within the safety database
Support to updates in the database configuration
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.
Bachelor's degree in life science
Fluent written and spoken English (C1 Advanced) and Spanish. Having proficiency in additional languages such as Chinese, Italian, French, or others will be highly valued
Experience: 1 year as a trainee, or similar, in pharmaceutical industry or CRO working on quality, data entry or pharmacovigilance.
Flexible and adaptable to changing situations/projects within the company/industry
Organization, planification and detail oriented
Multitasking
What we offer
It's a brilliant opportunity for someone with the right talents. Grifols understands you want a challenging and rewarding career in a critical function. Technical Drug Safety Officer help you grow professionally.
Information about Grifols is available at www.grifols.com. If you're interested in joining our company and you have what it takes, then don't hesitate to apply.
We look forward to receiving your application.
Grifols is an equal opportunity employer.
Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
Benefits package
Contract of Employment: Permanent position
Flexibility for U Program: 2 days remote working
Location: Sant Cugat del Vallès.
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Location: SPAIN : España : Sant Cugat del Valles : SC3
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