Senior Pharmacovigilance Specialist
hace 1 mes
Company Overview
Instituto Grifols Sa 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, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries.
About the Job
We are seeking a highly skilled Technical Drug Safety Officer to provide operational support for our global pharmacovigilance activities. The ideal candidate will ensure that pharmacovigilance deliverables meet the highest quality standards and global regulatory reporting timelines.
Responsibilities
- Participate in the collection, review, processing, evaluation, analysis, and compilation of safety data
- Process adverse event case reports for Grifols marketed products, including defining submissions required and conducting follow-ups with reporters
- Review weekly literature searches and updates in pharmacovigilance legislation
- Ensure compliance 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
Requirements
To succeed in this role, you must have a Bachelor's degree in life science and 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
You should have at least 1 year of experience as a trainee, or similar, in the pharmaceutical industry or CRO working on quality, data entry, or pharmacovigilance.
Salary and Benefits
The estimated salary for this position is $60,000 - $80,000 per year, depending on location and experience. Additionally, we offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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