Apply: Drug Safety Project Lead (Pharmacovigilance) - South Korea ...

A global clinical research organisation is seeking an experienced Drug Safety Project Lead to provide end-to-end safety oversight for clinical trials, with a strong focus on oncology and rare disease programmes.

This is a senior, client-facing role for an accomplished pharmacovigilance professional who can lead safety strategy, manage complex projects, and act as a subject matter expert across global studies.

Key Responsibilities

• Lead safety-related project meetings, including kick-off, internal team, and client governance meetings
• Develop and oversee Safety Management Plans and safety reporting strategies
• Provide full oversight of SAE/SUSAR case management from intake through regulatory submission
• Act as primary safety interface with sponsors, vendors, and cross-functional internal teams
• Support safety database set-up, configuration, and ongoing quality oversight
• Review and QC safety documents, reports, and regulatory submissions
• Support audits, inspections, CAPA management, and inspection readiness activities
• Mentor and support Safety Specialists and contribute to departmental initiatives
• Support bid defenses and resource planning as required

 
Requirements

• Bachelor’s degree in a life sciences or healthcare discipline
• 10+ years of clinical safety experience, including 5+ years in Pharmacovigilance ideally within a CRO environment.
• Hands-on experience with global safety databases, SAE case processing, and safety reporting
• Strong working knowledge of MedDRA, WHODrug, FDA regulations, ICH guidelines, and global PV requirements
• Proven experience supporting audits, inspections, and regulatory submissions (e.g. NDA/BLA environments)
• Excellent communication skills and the ability to explain complex clinical safety issues clearly
• Comfortable working in a fast-paced, global, project-driven environment

Preferred

• Early-phase oncology clinical trial experience

BeathChapman Pte Ltd