Senior/Principal Drug Safety Specialist

Thermo Fisher Scientific seeks a Senior/Principal Drug Safety Specialist for remote work in the Philippines to lead pharmacovigilance activities within clinical trial operations. The role involves managing adverse event data, ensuring regulatory compliance, and mentoring junior staff across a global portfolio of pharmaceutical and biotech clients.

Responsibilities

• Perform and oversee day-to-day pharmacovigilance activities including adverse event collection, monitoring, and assessment
• Review cases for quality, consistency, and accuracy; mentor less experienced staff members
• Maintain current knowledge of regulatory publications and therapeutic area developments
• Coordinate clinical trial implementation, endpoint assessments, and data safety monitoring activities
• Manage multiple tasks, meet strict timelines, and collaborate with clients, investigators, and third-party vendors

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 5+ years of relevant pharmacovigilance or drug safety experience
• Thorough understanding of pathophysiology, disease processes, and therapeutic areas
• Strong knowledge of global regulatory requirements and compliance procedures
• Proficiency in Microsoft Office and multiple database systems
• Excellent written and verbal communication skills in English
• Demonstrated critical thinking, problem-solving, and attention to detail