Senior Manager, SDM China Lead

About the role

The Senior Manager, SDM China Lead will head the Safety Data Management function for Merck in Beijing. The role is responsible for overseeing ICSR processing, medical coding, vocabulary governance and ensuring operational excellence across multiple sites.

Key responsibilities

• Lead ICSR case management teams to ensure quality, compliance and timely intake, triage, entry and analysis of safety cases.
• Oversee coding and terminology governance, approve high‑impact dictionary changes and drive cross‑functional harmonisation.
• Maintain compliance with SOPs, ICH‑GCP, GxP and other regulatory requirements and support audit/inspection readiness.
• Provide people‑management – set objectives, conduct reviews, coach staff and develop career plans.
• Support system roadmap, vendor governance and ensure technology and data flows meet functional and regulatory needs.

Required profile

• Bachelor’s degree in Life Sciences with at least 8 years of experience in a biopharmaceutical environment, including 2 years of people‑leadership; or an advanced degree with equivalent experience.
• Deep subject‑matter expertise in pharmacovigilance, safety data analysis and medical coding.

Required skills

• Safety Data Analysis and ICSR technical proficiency.
• Pharmacovigilance operations and medical‑coding leadership.
• Experience with safety databases, adverse‑event data tools and reporting mechanisms.
• Resource planning, capacity modelling and process optimisation.
• System testing, deployment readiness and business‑case development.
• Proficiency in PL/SQL.
• Knowledge of ICH‑GCP, GxP and related regulatory standards.