Your new company
My client is a leading biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life, specialising in Oncology, neurology, rare diseases, ophthalmology and immunology.
There is an opportunity for a Pharmacovigilance Quality Document Associate to join their Quality Document Review team on an initial 12-month contract.
Inside IR35 - PAYE or Umbrella
Hybrid - 1-2 days on-site Maidenhead
Your new role
As a highly motivated individual, your primary focus as a Pharmacovigilance Quality Document Reviewer will be to perform QC (quality review) review to ensure documents authored by the Safety Surveillance and Aggregate Reports (SSA) team or their vendors are of high quality; support process improvement and other SSA functions (e.g., vendor management, SharePoint management).
- Source data verification to ensure that all data and methods in all assigned documents agree with source documents, including checking text against database outputs.
- Editorial, technical, and scientific reviews for grammatical and stylistic consistency and accuracy
- Provide document findings so that appropriate actions can be taken by authors.
What you'll need to succeed
- Hold a university degree in a life science or Healthcare
- Writing and editing experience, within the pharmaceutical or biotech industry - medical writing, scientific editing and/or publishing.
- Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts. Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
- Exceptional English writing skills, comfortable with medical terminology, and the American Medical Association Manual of Style.
- Skilled with common data processing software (Excel, Pivot tables, PowerPoint, Microsoft Word, Business Objects).
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and living in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed)
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