Safety Writing Scientist (remote-based)

Are you a Safety Writing Scientist interested in working for a leading pharmaceutical organisation focused on providing innovative medicines for the treatment of patients with severe diseases then this role is for you! A fantastic new role has just opened where you will have the ability to work remotely on a contract basis.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Provide mentorship to relevant vendors and oversee the work, ensuring the final deliverables meet the organisation's quality guidelines.
• To lead preparation of Patient Safety and Medical Management deliverables, including planning, contributing to analysis strategy, writing, presentation when necessary, and review/approval of documents and deliverables in scope which include DSUR, SMR, PSUR, SSAR, RMP, PAER, SRM Strategy document, regulatory responses, submission documents, relevant and 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 and Medical Management deliverables, including compliance with regulatory requirements and compliant with agreed and defined timelines.
• Prepare ECMS templates to be compliant for regulatory submissions globally and act as ECMS superuser to provide guidance for Patient Safety and Medical Management 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.
• Project manage and champion continuous improvement initiatives and dedicated areas of expertise (e.g. Hub)
• Co-operate 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.
• Bringing value to patients by having ability to identify areas of risk to Patient Safety and Medical Management and report findings to stakeholders/PSU/line manager, etc.
• Ability to present analysed relevant adverse event/scientific/clinical/epidemiological data to a variety of audiences in an effective manner.

Requirements:

• 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.