Technical Drug Safety Officer
hace 2 semanas
Grifols is a global healthcare company that has been improving 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 over 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. As a Technical Drug Safety Officer, you will play a critical role in ensuring the highest quality pharmacovigilance deliverables and meeting global regulatory reporting timelines.
Responsibilities:- Participate in the safety data collection, review, processing, evaluation, analysis, and compilation.
- Process Grifols marketed products adverse event case reports, including defining 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 manage 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.
- Bachelor's degree in life science.
- Fluent written and spoken English (C1 Advanced) and Spanish.
- Proficiency in additional languages such as Chinese, Italian, French, or others will be highly valued.
- 1 year of experience as a trainee, or similar, in the pharmaceutical industry or CRO working on quality, data entry, or pharmacovigilance.
- Flexible and adaptable to changing situations/projects within the company/industry.
- Organization, planning, and detail-oriented.
- Multitasking.
- 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 helps you grow professionally.
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. #LI-Hybrid #LI-ER1 Location: SPAIN: España: Sant Cugat del Valles: SC3 Learn more about Grifols. #J-18808-Ljbffr
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