Senior Pharmacovigilance Systems & Innovation Specialist

Planet Pharma; Normanton on Trent; Híbrido; GBP 70.000 - 95.000; Jornada completa

Descripción de la vacante

Planet Pharma in the UK is seeking a Safety Systems & Innovation Specialist to bridge pharmacovigilance, IT and business operations across global safety systems. This role focuses on enhancing Veeva Vault Safety, supporting upgrades, change controls, and technology-driven improvements.

The ideal candidate has 5+ years in pharmacovigilance systems, strong business analysis, and experience in GxP environments, with stakeholder management and a drive to explore AI opportunities in patient safety.

Formación

• 5+ years' experience supporting Pharmacovigilance/Drug Safety systems.
• Strong knowledge of pharmacovigilance processes and operations.
• Experience working within GxP-regulated environments.
• Experience supporting validated computer systems.
• Excellent business analysis skills translating operational requirements into system solutions.
• Strong stakeholder management and communication skills.
• Experience supporting system implementations, upgrades, releases and change management activities

Responsabilidades

• Support and enhance safety systems used across global pharmacovigilance and patient safety operations.
• Contribute to the ongoing optimisation and stabilisation of Veeva Vault Safety following a recent migration.
• Support recurring system releases and upgrade cycles, including multiple Veeva upgrades annually.
• Coordinate bi-annual MedDRA upgrades and associated activities.
• Gather, analyse and translate business requirements into system solutions.
• Act as a key liaison between business stakeholders, IT teams, vendors and support partners.
• Support change controls, incident investigations, system enhancements and process improvements.
• Drive technology assessments, pilots, innovation initiatives and potential AI use cases within patient safety.
• Prepare and maintain validation documentation including URS, Data Flow Documents, Data Integrity Risk Assessments, UAT Scripts & Execution Documentation, Release Notes, Business Communications.
• Participate in system validation, periodic reviews, CAPAs, deviations and GxP compliance activities.
• Collaborate with global stakeholders to continuously improve safety processes and supporting technologies

Conocimientos

Pharmacovigilance systems

Stakeholder management

Business analysis

GxP compliance

Herramientas

Veeva Vault Safety

Oracle Argus

ArisGlobal

Power BI

Descripción del empleo

Safety Systems & Innovation Specialist

Slough Area (Hybrid, 2-3 days onsite) Long-Term Contract Full-Time | 37.5 Hours Per Week

? Are you an experienced Pharmacovigilance Systems professional who enjoys bridging the gap between business operations, technology, and patient safety?

We're partnering with a leading global biopharmaceutical organisation to find a Safety Systems & Innovation Specialist who will play a key role supporting and enhancing the technology landscape that underpins patient safety and pharmacovigilance activities.

This is a highly visible, business-facing role where you'll work closely with Safety Operations, IT teams, external suppliers, and system experts to drive system improvements, support global upgrades, and identify innovative technology opportunities across the safety systems ecosystem.

What You'll Be Doing

• Support and enhance safety systems used across global pharmacovigilance and patient safety operations
• Contribute to the ongoing optimisation and stabilisation of Veeva Vault Safety following a recent migration
• Support recurring system releases and upgrade cycles, including multiple Veeva upgrades annually
• Coordinate bi-annual MedDRA upgrades and associated activities
• Gather, analyse and translate business requirements into system solutions
• Act as a key liaison between business stakeholders, IT teams, vendors and support partners
• Support change controls, incident investigations, system enhancements and process improvements
• Drive technology assessments, pilots, innovation initiatives and potential AI use cases within patient safety
• Prepare and maintain validation documentation including:URS
• Data Flow Documents
• Data Integrity Risk Assessments
• UAT Scripts & Execution Documentation
• Release Notes
• Business Communications
• Participate in system validation, periodic reviews, CAPAs, deviations and GxP compliance activities
• Collaborate with global stakeholders to continuously improve safety processes and supporting technologies

What We're Looking For

5+ years' experience supporting Pharmacovigilance / Drug Safety systems

Strong knowledge of pharmacovigilance processes and operations

Experience working within GxP-regulated environments

Experience supporting validated computer systems

Excellent business analysis skills with the ability to translate operational requirements into system solutions

Strong stakeholder management and communication skills

Experience supporting system implementations, upgrades, releases and change management activities

Preferred Experience

• Veeva Vault Safety
• Oracle Argus
• ArisGlobal solutions
• Safety database administration and support
• Safety intake systems
• Signal detection and management tools
• Literature screening platforms
• Safety agreement management systems
• Reporting platforms including Power BI
• Licensed partner management tools
• Process automation solutions

Why Consider This Opportunity?

• Work at the intersection of Patient Safety, Technology and Innovation
• Influence the future direction of safety systems and digital transformation initiatives
• Exposure to cutting-edge technologies, including AI opportunities in Pharmacovigilance
• Join a highly collaborative international environment
• Long-term contract with strong extension potential
• Opportunity to work on a broad portfolio of business-critical safety systems

Please note: This is not a software development or programming role. We're seeking someone with strong Pharmacovigilance Systems, Business Analysis, Validation and Safety Operations experience who can bridge business needs and technology solutions.

If you have experience supporting safety systems in a regulated environment and enjoy driving technology-enabled improvements across pharmacovigilance operations, we'd love to hear from you.