As a PV Scientist Quality Document Manager, you will ensure that all documents authored by the Safety Surveillance and Aggregate reports team or vendors meet Biogen’s highest quality standards
Job Summary
As a PV Scientist Quality Document Manager, you will ensure that all documents authored by the Safety Surveillance and Aggregate reports team or vendors meet Biogen’s highest quality standards.
This role involves verifying data accuracy, ensuring stylistic consistency, maintaining compliance with the style guide, and collaborating with internal and external stakeholders to uphold pharmacovigilance quality.
Biogen offers a pioneering spirit and a collaborative environment where individual contributions make a significant impact, fostering learning, growth, and inclusion.
Matching Summary
As a PV Scientist Quality Document Manager, you will ensure that all documents authored by the Safety Surveillance and Aggregate reports team or vendors meet Biogen’s highest quality standards.
Skills & Requirements
Must-have
Pharmacovigilance document quality management
Scientific and medical data review
Source data verification
Vendor oversight and collaboration
Quality control checklist maintenance
Process improvement for documentation
Proficient in Excel, PowerPoint, Word
Nice-to-have
Strong organizational skills
Collaborative team environment
Exceptional English writing skills
Familiarity with clinical trial safety regulations
Ability to present quality trends
Hybrid work model with office attendance
Key Requirements
Bachelor’s Degree in biologic, natural science, or healthcare
Experience in pharmacovigilance or medical writing
Significant writing and editing experience in pharma/biotech
Knowledge of clinical trial and post-marketing safety regulations