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Senior Regulatory Affairs Associate

Salary

Negotiable

Location

Welwyn Garden City, Hertfordshire, United Kingdom

Job type

Temporary

Sector

Scientific

Job ref

X3-1280427

Job posted

Posted 3 hours ago

Senior Pharmacovigilance Scientist

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

Please follow the link below to apply.

Apply now

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