Quality Recruiting. Established Experts.

Safety Writing Scientist

Reference Number: 3723
Location: Remote

Our client is global biopharmaceutical company. They have asked us to assist them in their search for a Safety Writing Scientist.

Major tasks and responsibilities will include:

  • Leads preparation of Patient Safety deliverables.
  • Ensures final deliverables meet quality guidelines, are compliant with regulatory requirements and with defined timelines.
  • Provides mentorship to relevant vendors and oversees the work.
  • Performs literature review and summary of literature for AR, RMP, epidemiology, product renewals, safety evaluations.
  • Prepares EDMS templates to be compliant for regulatory submissions globally and act as EDMS super-user to provide guidance for Patient Safety colleagues and contract organizations.
  • Develops strategies for data searches in support of document preparation.
  • Actively participates in team/product meetings to give input based on scientific expertise and awareness of business implications.
  • Presents analyzed relevant adverse event/scientific/clinical/epidemiological data to a variety of audiences.
  • Project manages and champions continuous improvement initiatives.
  • Collaborates in the planning, preparation, and review of epidemiologic/scientific manuscripts, abstracts, posters, etc., for submissions to scientific journals/conferences, including generation of lay language summaries for patients, as necessary.
  • Brings value to patients by having the ability to identify areas of risk to patient safety and report findings to stakeholders/PSU/line manager, etc.

We seek candidates with the following qualifications:

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

If interested, please email your resume as a Word attachment to us, reference 3723.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.