OverviewIn this role you will support pharmacovigilance project delivery by coordinating cross?functional teams and ensuring regulatory compliance.
You will help manage communications, documentation, and documentation tools while supporting audits and inspections.
You'll contribute to safety reporting and project governance, enabling timely insights for sponsors.
This is a chance to shape PV processes within a mission-driven environment that improves patient outcomes.
Compensaciones / Beneficiosgrowth opportunities
adaptable work arrangements
opportunity to work on life?saving therapies
collaborative culture
professional development
ResponsabilidadesCoordinate and oversee cross?functional study teams with DSOs, SPMs and management
Ensure compliance with SOPs and ICH/GCP best practices
Maintain project communications, minutes, agendas, and action logs
Update and track project budgets and out?of?scope services
Generate SAE/SUSAR/AESI report listings for sponsors or team members
Support KPI collation and governance slide decks
Keep TMF documents collated and indexed




Create and maintain project SOP indices, study team lists, and distribution lists
Assist with kickoff meeting materials and training matrices
Prepare for sponsor or regulatory audits and inspections
Requisitos principalesBachelor's degree in Life Sciences or related field
1 year of professional experience in clinical research, healthcare, business, finance, or project management (preferred)
Experience with Pharmacovigilance (preferred)
Basic knowledge of ICH/GCP regulations
Working knowledge of FDA guidance, EU directives, ISO*, drug/device development, and clinical monitoring
Basic project management terminology and guidelines
Strong MS Office skills
Fluent in English
Strong communication and coordination across cross?functional teams
Attention to detail and organizational skills
Proactive problem solving and accountability
MS Office proficiency
Basic pharmacovigilance knowledge
Familiarity with ICH/GCP and regulatory frameworks

📌 Pharmacovigilance Project Specialist (España)
🏢 Premier Research
📍 España