Technical Drug Safety Officer
hace 2 semanas
We are seeking a highly skilled Technical Drug Safety Officer to join our international team at Grifols, a global healthcare company dedicated to improving the health and well-being of people around the world.
About the RoleAs a Technical Drug Safety Officer, you will be responsible for providing operational support for global pharmacovigilance activities, ensuring pharmacovigilance deliverables meet global regulatory reporting timelines, and managing the integrated database utilized by worldwide Grifols pharmacovigilance personnel.
Key Responsibilities- Participate in the safety data collection, review, processing, evaluation, analysis, and compilation.
- Process Grifols marketed products adverse event case reports, including definition of submissions required and conducting follow-up with reporters.
- Review the weekly literature search and updates in pharmacovigilance legislation.
- Comply with archiving tasks for deliverables and relevant documents.
- Compile information for and participate in the preparation of periodic safety update reports.
- Support 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 the review and update of SOPs, working practices, or conventions.
- Use queries for data extraction for different PV documents.
- Ensure data consistency and integrity within the safety database.
- Support updates in the database configuration.
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.
- 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.
Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we 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.
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