Planet Pharma
Safety Systems & Innovation Specialist
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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
- 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
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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
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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.
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