Overview

In 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 / Beneficios

- growth opportunities
- adaptable work arrangements
- opportunity to work on life‑saving therapies
- collaborative culture
- professional development

Responsabilidades

- Coordinate 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 principales

- Bachelor’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, ISO14155, 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 - Premier Research (España)
🏢 Premier Research
📍 España