Senior Pharmacovigilance Scientist

Your new company My client is a global 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 neurological diseases. There is an opportunity for a Senior Pharmacovigilance Scientist to join their Pharmacovigilance team. Inside IR35 Remote working (must be currently living in the UK)

Your new role As a highly motivated individual, you will serve as a product lead for Pharmacovigilance activities within Safety. The Senior PV Scientist will lead the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluate safety data and signals as part of ongoing pharmacovigilance activities. This includes synthesis of data from multiple sources and authoring signal evaluation reports and responding to safety questions from regulatory authorities.

You will also lead Aggregate Report management, including strategy, review and finalisation of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, and Risk Management Plans (RMPs), and authoring safety sections in aggregate reports.

What you'll need to succeed Life sciences degree. Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. With several years of hands-on Pharmacovigilance / Drug safety experience in a pharmaceutical company. Strong experience in authoring aggregate safety reports, safety signal management and responses to regulatory agency requests. Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format Knowledge of common safety database systems. Demonstrates leadership and interacts collaboratively and effectively in a team environment, as well as with external colleagues Applies clinical judgment to interpret case information. Strong organisational skills, including the ability to prioritise independently with minimal supervision. Excellence in communication Strong innovation, decision-making and problem-solving skills

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 residing 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 03330106292

Desired Skills and Experience Pharmacovigilance