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 Senior Pharmacovigilance Scientist specialising in Safety signal management / detection to join their Pharmacovigilance team on a 12-month initial contract.
Remote
12 Month + Contract
INSIDE IR35
PAYE - Up to £80 p/h (depending on experience)
Umbrella - Up to £100 p/h (depending on experience)
Your new role
As the Senior Pharmacovigilance Scientist, you will serve as a product lead for Pharmacovigilance activities within Safety. The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities (detection, evaluation, prioritisation, and assessment of safety signals related to drug safety), aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.
The Senior PV Scientist also serves as a Subject-Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product-specific information. In this capacity, the Sr. PV Scientist is critical to ensuring products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorisation remains in good standing.
What you'll need to succeed
A scientific degree, advanced degree preferred (e.g., M.Sc., PhD, MPH, PharmD).
Expert experience of pharmaceutical industry and pharmacovigilance, including safety signal management - detection, evaluation, prioritisation, and assessment of safety signals related to drug safety.Expert experience of Filing EU responses
Expert experience of HA (Health Authority) responses
Expert knowledge of Risk Management and RMP's
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)
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