Location: Welwyn Garden City (Hybrid) Contract: 12-Month Fixed-Term Contract
We are seeking an experienced Senior Pharmacovigilance Scientist to join a central safety operations team, focused on ensuring high-quality, compliant ICSR processing and safety data management to support patient safety.
Key Responsibilities
Oversee ICSR case processing and ensure compliance with global regulations
Manage and monitor service providers, using metrics and performance insights
Act as a subject matter expert, supporting stakeholders and regulatory inspections
Drive process improvements and identify/implement CAPAs
Assess the impact of new or updated regulatory requirements
Experience Required
Strong background in pharmacovigilance and ICSR processing
Knowledge of global safety regulations (ICH, EU GVP, FDA)
Experience in regulatory affairs and vendor oversight
Proven ability to manage complex projects and influence stakeholders
Desirable: medical device safety reporting experience
Profile
Proactive, quality-driven, and solutions-focused
Strong communicator with the ability to simplify complex topics
Adaptable, collaborative, and comfortable working in a fast-paced environment