Senior Pharmacovigilance Scientist, Quality Document Manager

General Information:

• Start Date: ASAP
• Duration: 1 year
• Extension: to be discussed
• Contract Type: temporary contract via Randstad (employment)

Tasks & Responsibilities:

• 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 activ...