Safety (PV) Writing Scientist - Freelance - California
MSI Pharma is working with a global biopharma to source a Safety Writing Scientist to support the Global Patient Safety Unit for an initial 6 month freelance contract.
client are based in California and will offer remote working
The role;
· As the Safety Writing Scientist, you will be writing benefit-risk assessments, safety risk management strategies, safety signal assessments, regulatory submissions, aggregate reports, and publications.
· You will lead the preparation of Patient Safety deliverables, including planning, contributing to analysis strategy, writing, presentation as well as review and approval of documents and deliverables in scope: DSUR, SMR, PBRER /PSUR, SSAR, SOV, RMP, PAER, SRM Strategy document, regulatory responses, submission documents, relevant and other regulatory and safety annual reports.
· You will provide mentorship to relevant vendors and oversee the work, ensuring the final deliverables meet 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 time-lines
· Present analysed relevant adverse event/scientific/clinical/epidemiological data to a variety of audiences
· 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
You should have:
Bachelor's Science degree or the equivalent is an absolute must
As is extensive experience in pharmacovigilance, medical writing, including working with vendors, clinical safety or clinical development
A good understanding of applicable regulations in pharmacovigilance and clinical development
Have the ability to project manage deliverables in a matrix environment with competing priorities
