Safety Writing Scientist:

Raleigh North Carolina

The Safety Writing Scientist will provide scientific analysis and writing acumen to effectively articulate for benefit-risk assessments, safety risk management strategies, safety signal assessments, regulatory submissions, aggregate reports, and publications.

In this role, you will also lead, project manage, and contribute to projects (including mentoring of vendor) as assigned to deliver the project in accordance with global regulatory submission requirements (for external documents), within planned timelines (and budget as appropriate), and according to required standards of quality and compliance.




  • Lead preparation of Patient Safety deliverables, including planning, contributing to analysis strategy, writing, presentation when necessary, and review/approval of documents and deliverables in scope: DSUR, SMR, PSUR, SSAR, SOV, RMP, PAER, SRM Strategy document, regulatory responses, submission documents, relevant and other regulatory/safety annual reports.
  • Provide mentorship to relevant vendors and oversee the work, ensuring the final deliverables meet the UCB quality guidelines.
  • Perform literature review and summary of literature for AR, RMP, epidemiology, product renewals, safety evaluations
  • Assure quality and consistency across Patient Safety deliverables, including compliance with regulatory requirements and compliant with agreed and defined timelines
  • Prepare EDMS templates to be compliant for regulatory submissions globally and act as EDMS superuser to provide guidance for Patient Safety colleagues and contract organizations
  • Develop strategies for data searches in support of document preparation
  • Actively participate in team/product meetings to give input based on scientific expertise and awareness of business implications
  • Present analyzed relevant adverse event/scientific/clinical/epidemiological data to a variety of audiences
  • Project manage and champion continuous improvement initiatives
  • Collaborate in the planning, preparation, and review of epidemiologic/scientific manuscripts, abstracts, posters, etc for submission to scientific journals/conferences including generation of lay language summaries for patients as necessary
  • Bring value to patients by having abilitiy to identify areas of risk to patient safety and report findings to stakeholders/PSU/line manager, etc.


Experience and Education:


  • Bachelor's degree required
  • Experience in pharmacovigilance, medical writing (including working with vendors), clinical safety or clinical development (4 years minimum)
  • Competent in knowledge and understanding of applicable regulations in pharmacovigilance and clinical development
  • Demonstrated experience working in a matrix environment
  • Ability to gather data from relevant sources using appropriate methods and logic, and to interpret, analyze, draw meaningful conclusions and clearly present scientific and technical data in verbal and written format
  • Ability to project manage deliverables in a matrix environment with competing priorities


Basic Qualifications