Connecting...

Location
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-24522
Contact
Ann Marie Christopher
Posted
約12時間前
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