PV Scientist Quality Document Manager
Core
Manage quality of pharmacovigilance documents (Safety Surveillance and Aggregate reports) authored by internal teams and vendors to ensure data accuracy, stylistic consistency, and compliance with Biogen standards.
Role type
Senior IC quality document manager (pharmacovigilance)
Builds
High-quality SSA documentation for safety surveillance and aggregate reporting
Domain
Pharmaceutical industry + Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Source data verification, editorial/technical/scientific review, vendor oversight, quality metrics planning, checklist maintenance, template creation, process improvement, data interpretation/presentation, medical terminology fluency, common data processing software proficiency
Preferred skills
Experience in medical writing, scientific editing, publishing, drug development processes, clinical trial safety regulations, post-marketing safety regulations
Technologies
Excel, PowerPoint, Microsoft Word, Business Objects
Responsibilities
Perform source data verification, conduct editorial and scientific reviews, identify and resolve document issues, oversee vendor work, maintain QC checklists and templates, present quality trends, drive process improvements
Seniority
Senior, hands-on IC
