Remote Consultant Safety Writer/ Safety Medical Writer/Aggregate Report Writer/Pharmacovigilance
Title: Consultant Safety Writer
Duration: 4 months+
Intro: The Consultant Safety Writer 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 lead and contribute to projects as assigned to deliver the project in accordance with global regulatory submission requirements within planned timelines 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, PSUR, RMP, PAER, SRM Strategy document, regulatory responses, submission documents, relevant and/or other regulatory/safety annual reports.
- 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
- 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 ability to identify areas of risk to patient safety and report findings to stakeholders/PSU/line manager, etc.
Experience and Education:
- Bachelor's degree required; clinical degree preferred i.e., MPH, RPh, RN.
- Experience in pharmacovigilance, medical writing, clinical safety, and signal detection (3 years minimum)
- Competent in knowledge and understanding of applicable regulations in pharmacovigilance and clinical development
- Demonstrated experience drafting regulatory responses for the FDA preferred
- 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
Sthree US is acting as an Employment Business in relation to this vacancy.