PV / Medical Writer Quality Document Associate - PSUR / DSUR
Your new company
We are supporting a leading global biopharmaceutical organisation in the search for a Pharmacovigilance Quality Document Associate to join their Safety function on a 12-month contract.
This opportunity is ideal for candidates with medical writing experience, strong quality control (QC) experience with aggregate safety reports (e.g., PSURs, DSURs) and exceptional scientific editing skills and excellent pivot table and excel spreadsheet experience.
Your new role
You will be responsible for performing rigorous QC reviews of pharmacovigilance documents, PSURs and DSURs, ensuring the highest standards of accuracy, consistency, and compliance across Safety Surveillance and Aggregate Reporting outputs. This involves data checking against sources and making pivot tables, and using Excel spreadsheets.
You will also contribute to process improvement initiatives, vendor oversight, and quality standards development, making this a highly collaborative and impactful role within the PV quality space.
What you'll need to succeed
- Bachelor's degree in Life Sciences, Pharmacy, or related healthcare discipline
- Typically, 2-3+ years' experience in medical writing, editing, or PV quality/QC roles within pharma/biotech
- Proven experience in QC of aggregate safety reports (PSURs, DSURs essential)
- Strong editing and proofreading skills, with excellent attention to detail and consistency
- Experience in scientific/medical writing, editing, or publishing within pharma/biotech
- Ability to data check against sources and create pivot tables
- Excel spreadsheet experience
- Familiarity with working against style guides (e.g., AMA Manual of Style preferred)
- Strong organisational skills and ability to prioritise independently
- Effective collaborator with experience working across cross-functional teams and vendors
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 must be based in the UK.
If you are an experienced Medical Writer with strong expertise in QC of aggregate safety reports (PSURs and DSURs) and are available for your next contract, I'd love to hear from you. Click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on