Your new company
My client, a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability and which is focused on improving people's quality of life, specialising in Oncology, neurology and rare diseases, and has a position available for a Clinical Pharmacovigilance Scientist to join their Global Patient Safety team on a 6-month initial contract within their early development oncology / immune-oncology arena.
Hybrid - 1 day per week in London
6 Month + Contract
OUTSIDE IR35
Your new role
As the Global Clinical Pharmacovigilance Scientist, you will support the Global Patient Safety (GPS) early development oncology (specifically FIH) / immune-oncology Therapy Area through safety surveillance activities, including scientific analyses, case reviews, literature reviews, data assessment, signal management, and risk assessment, evaluation of product quality issues and emerging safety issues, including contribution to safety documents, aggregate reports, (d)RMPs and responses to health authority requests, submission, interactions etc. for allocated assets/products, projects and activities.
Support definition of safety strategy for FIH (First in Human) trials and work with the safety physician on the IND/CTA enabling documents.
Interact with vendors, CROs and business partners as stipulated in the SDEA, evaluation of product quality issues and the overall safety strategy
What you'll need to succeed
In order to apply for the Global Clinical Pharmacovigilance Scientist role, you must possess:
A scientific degree, advanced degree preferred (e.g., MSc, PhD, MPH, PharmD).
Expert experience of pharmaceutical industry and pharmacovigilance, including aggregate report writing and signal management.
Expert experience of early development oncology (specifically FIH) or/ and immune oncology
Strong knowledge of pre- and post‑marketing pharmacovigilance legislation (CTR, GVP Modules, ICH/CIOMS).
Experience with EMA and FDA regulatory submissions.
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'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)
:quality(80))
:quality(80))
:quality(80))