Safety Writing Scientist

Circa £35ph PAYE
11 Jun 2021
11 Jul 2021
Hendre Moolman
Full Time
Contract Type
Experience Level
Experienced (non-manager)
CK Group are recruiting for a Safety Writing Scientist to join a biopharmaceutical company in a remote based contract role for an initial 6-month period. Role Inside IR35.

This company is a successful global biopharmaceutical company that discovers and develops innovative medicines and solutions for people living with severe diseases of the immune or central nervous systems. The company works across approximately 40 countries across Europe and the rest of the world.

The Role:
The main purpose of the role will be to
- Work on benefit-risk assessments, safety risk management strategies, safety signal assessments, regulatory submissions, aggregate reports, and publications.
- Lead preparation of Patient Safety and Medical Management deliverables, including planning, contributing to analysis strategy, writing, 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.

Further responsibilities will include:
- Collaborate in the planning, preparation, and review of epidemiologic/scientific manuscripts, abstracts, posters for submission
- Prepare ECMS templates to be compliant for regulatory submissions globally and act as ECMS superuser to provide guidance for Patient Safety and Medical Management
- Develop strategies for data searches in support of document preparation

Your Background:
To succeed in this role, you will come from a background in Life Science with experience in pharmacovigilance, medical writing (including working with vendors), clinical safety or clinical development
- Competent in knowledge and understanding of applicable regulations in pharmacovigilance and clinical development
- Demonstrated experience working in a matrix environment

Entitlement to work in the UK is essential. Please quote reference 50882.