Global Pharmacovigilance Specialist
hace 1 semana
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 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 provide operational support for global pharmacovigilance activities for Grifols investigational and marketed products. You will ensure that pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines.
Your responsibilities will include:
- Participating in the safety data collection, review, processing, evaluation, analysis, and compilation
- Processing Grifols marketed products adverse event case reports, including defining submissions required and conducting follow-up with reporters
- Reviewing the weekly literature search
- Reviewing updates in pharmacovigilance legislation
- Complying with archiving tasks for deliverables and relevant documents
- Compiling information for and participating in the preparation of periodic safety update reports
- Supporting the pharmacovigilance staff involved in audits and inspections
- Providing training to concerned personnel based on the training plan and managing training documentation and deliverables within relevant company departments
- Supporting the review and update of SOPs, working practices, or conventions
- Using queries for data extraction for different PV documents
- Ensuring data consistency and integrity within the safety database
- Supporting 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements:
- 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
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