Safety Systems & Innovation Specialist

We are currently seeking an experienced Safety Systems &​ Innovation Specialist to join a leading global pharmaceutical organisation and support the systems underpinning Pharmacovigilance and Patient Safety operations .

This is a highly business-facing role, working at the intersection of Pharmacovigilance, Safety Systems, IT and external technology partners . You will help drive system improvements, technology adoption and validated changes across a broad Safety Systems portfolio.

Key responsibilities will include:

• Supporting and enhancing Safety and Pharmacovigilance systems in a regulated GxP environment
• Translating business requirements and operational needs into clear system requirements
• Supporting system implementations, upgrades, releases and process changes
• Working closely with

Safety Operations, IT, suppliers and other technical/business stakeholders

• Supporting incident investigations, issue assessment, prioritisation and solution design
• Developing and managing business-focused validation deliverables, including:
• URS
• Data flows
• Data integrity risk assessments
• UAT test cases and execution
• Release documentation and communications
• Supporting

CSV activities , change controls, deviations, CAPAs and periodic system reviews

• Evaluating existing processes and systems to identify opportunities for optimisation
• Researching and assessing new technologies, including potential innovation and automation opportunities
• Supporting pilots, technology evaluations and business-case development
• Contributing to user training, procedure updates and change communications
• Managing priorities and stakeholders independently across multiple initiatives

About You

We are looking for someone with 5+ years of relevant experience across Pharmacovigilance/Safety Systems, ideally with experience in a pharmaceutical or similarly regulated environment.

You should have:

• Strong experience supporting Safety/PV systems
• Broad knowledge of

Pharmacovigilance processes and operations

• Experience working with validated computerised systems in a GxP environment
• Knowledge and practical experience of

Computer System Validation (CSV)

• Experience with UAT, requirements gathering and business analysis
• Experience supporting system upgrades, implementations, releases or system changes
• Ability to produce and manage validation and business documentation
• Strong stakeholder management skills across business, IT and external suppliers
• Excellent communication skills, with the ability to explain complex technical concepts to non-technical stakeholders
• Strong analytical and critical-thinking skills
• The ability to work autonomously, prioritise effectively and drive issues through to resolution

Systems Experience

Experience with Veeva Vault Safety would be highly desirable, although candidates with strong experience in other major Pharmacovigilance/Safety platforms will also be considered.

Relevant experience could include:

• Veeva Vault Safety / Veeva Safety
• Oracle Argus
• ArisGlobal / LifeSphere
• Safety database implementations or migrations
• Case intake and processing systems
• Signal detection and management systems
• Literature screening platforms
• Safety reporting systems
• Safety agreement management
• Process automation and reporting tools

Experience supporting a migration between safety systems , post-go-live stabilisation/hypercare or recurring system upgrade cycles would be particularly advantageous.

Why this opportunity?

If you have a strong combination of Pharmacovigilance, Safety Systems, CSV/validation and business analysis experience , we would be keen to hear from you.