Senior Pharmacovigilance Scientist

ZipRecruiter; London; Remote; GBP 60,000 - 80,000; Full time

Job summary

A global biopharmaceutical company is seeking a Senior Pharmacovigilance Scientist to lead pharmacovigilance activities. The role involves managing safety data, authoring reports, and responding to regulatory inquiries. Candidates must have a life sciences degree and significant experience in drug safety.

Qualifications

• Several years of hands-on Pharmacovigilance experience in a pharmaceutical company.
• Strong experience in aggregate safety reports and safety signal management.

Responsibilities

• Lead the signal management process for assigned product(s).
• Manage Aggregate Reports including PSURs and Risk Management Plans.

Skills

Pharmacovigilance

Drug Safety

Communication

Problem-Solving

Leadership

Education

Life Sciences Degree

Tools

Safety Database Systems

Job description

Job Description

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 based 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 aggregate safety reports and 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

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

Desired Skills and Experience

Pharmacovigilance , Drug Safety , PV, aggregate reports, pharmaceutical, safety signal management, safety surveillance, RMP, PSUR, PBRER