Senior Pharmacovigilance Scientist, Quality Document Manager

• Perform QC Review of documents produced by SSA, including:
  • Source data verification to ensure that all data and methods in all assigned documents agree with source documents, including checking text against database outputs. 
  • Editorial, technical, and scientific reviews for grammatical and stylistic consistency and accuracy and in line with Biogen Style Guide.
  • Provide document findings so that appropriate actions can be taken by authors. Where needed, meets with document author to discuss findings and strategize the next steps (in case error lies within the source document) including support with the development of preferred text. 
• Review vendor authoring and QC as part of oversight activities. 
• Support the creation of training material for new staff members and vendors on quality requirements.
• Support the preparation of aggregate report quality trends for discussion at regular team meetings.
• Assist with the development and maintenance of training materials and Job Aids.
• Assist with maintenance of SSA templates and QC checklists.
• Assist with SSA process improvement initiatives for quality documentation and technical tools/systems, including developing new templates.
• Represent the department, where appropriate, in cross-functional improvement initiatives.
• Perform general administrative tasks such as maintaining spreadsheets and communicating summaries and results with the relevant stakeholders.
• Provide support to other functions within SSA, which may include activities outside of QC review (e.g., vendor management, aggregate report processes, SharePoint maintenance, literature activities).
• Train new staff members and vendors on quality requirements within SSA team.

Your Profile:
 

• Bachelor’s Degree in biologic or natural science, or health care discipline.
• Minimum 2-3 years writing and editing experience, preferably in the pharmaceutical or biotech industry. Previous experience in pharmacovigilance, medical writing, scientific editing and/or publishing.
• Exceptional English writing skills, comfortable with medical terminology, and American Medical Association Manual of Style.
• Familiarity with Pharmacovigilance and Drug Development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts. Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
• Interacts collaboratively and effectively in a team environment.
• Strong organizational skills, including the ability to prioritize independently.
• Skilled with common data processing software (Excel, PowerPoint, Microsoft Word, Business Objects). 

Sounds interesting? Apply now! We are looking forward to receiving your applications.