!*Senior Pharmacovigilance - Maidenhead - Global Biotech!*

JR United Kingdom; Maidenhead; Remote; GBP 60,000 - 80,000; Full time

Job summary

A global biotech company is seeking a Senior Pharmacovigilance Scientist to lead safety signal management and support clinical trial activities. The role requires extensive experience in pharmacovigilance and expertise in safety regulations. This position is fully homebased in the UK, offering a chance to contribute to innovative medicines for complex conditions.

Benefits

Referral scheme with rewards

Qualifications

• 7+ years of pharmacovigilance experience in the pharmaceutical industry.
• Understanding of GVP guidelines.

Responsibilities

• Lead the signal management process, including detection and documentation.
• Manage aggregate safety reports, including PSURs and DSURs.
• Collaborate with Global Safety Officers on clinical trial safety activities.

Skills

Safety Surveillance

Signal Management

Data Analysis

Tools

Argus

ARISg

Job description

Senior Pharmacovigilance - Maidenhead - Global Biotech

Job Details

• Location: Fully homebased in the UK
• FTE: 12 months (with potential to extend)
• Rate: Very good rate
• Job Category: Other
• EU work permit required: Yes
• Job Views: 4
• Posted: 12.05.2025
• Expiry Date: 26.06.2025

Company Overview

Planet Pharma collaborates with a leading biotechnology company specializing in neurology, neuropsychiatry, immunology, and rare diseases. The company develops innovative medicines for complex conditions such as Alzheimer’s disease, multiple sclerosis, and spinal muscular atrophy. Known for its scientific research and commitment to healthcare, it advances global medical science.

Role Objective

The Senior PV Scientist serves as the product lead for pharmacovigilance activities within Safety. Key responsibilities include managing safety signal processes, preparing aggregate reports (PSURs, DSURs, Line Listings, RMPs), addressing safety inquiries from stakeholders, and reviewing scientific literature for safety data. The role also supports clinical trial PV activities and acts as a Subject Matter Expert on safety regulations and data analysis for cross-functional teams.

Key Responsibilities

• Lead the signal management process, including detection, tracking, documentation, and decision-making regarding safety signals. Synthesize data and author evaluation reports. Manage literature reviews for safety information.
• Respond to safety questions from regulatory authorities.
• Manage aggregate safety reports, including strategy, review, and finalization of PSURs, DSURs, Pharmacovigilance Plans, REMS, and RMPs.
• Collaborate with Global Safety Officers and Safety MDs on clinical trial safety activities.

Requirements

• 7+ years of pharmacovigilance experience in the pharmaceutical industry.
• Experience with safety surveillance and signal management.
• Understanding of GVP guidelines.
• Experience with systems such as Argus, ARISg, etc.

If this role isn’t suitable, please consider referring qualified candidates. Planet Pharma offers a referral scheme with rewards!