Manager, Safety Data Management (SDM) China Lead

About the role

The Manager, Safety Data Management (SDM) China Lead oversees teams responsible for ICSR processing, safety case analysis, medical coding, and vocabulary governance. The role ensures operational excellence, regulatory compliance, and alignment with global safety data standards.

Key responsibilities

• Lead ICSR case management and encoding teams, ensuring quality, readiness, and compliance across intake, triage, entry, and analysis.
• Identify and communicate technology or process changes affecting case‑management workflows and coordinate readiness.
• Oversee coding and vocabulary governance, harmonising terminology across programs and approving high‑impact dictionary changes.
• Maintain compliance with SOPs, ICH‑GCP, GxP, and other regulatory requirements; monitor performance metrics and support audit/inspection readiness.
• Provide input on SDM resource planning, align priorities, and drive high‑quality, coordinated delivery across safety operations, IT, and process‑excellence functions.

Required profile

• Bachelor's degree in Life Sciences with at least 8 years of relevant experience (or Master/Doctorate with 3 years), including 4 years in a biopharmaceutical company.
• People‑management experience (indirect or matrix leadership) and deep subject‑matter expertise in pharmacovigilance and medical coding.

Required skills

• Safety Data Analysis
• ICSR processing
• Medical coding
• Pharmacovigilance operations
• Safety databases and AE data tools
• Clinical development processes
• Performance metrics analysis
• Workflow testing and validation
• Clinical and safety systems, dashboards, reporting tools, coding platforms