Safety Data Lead I

Merck & Co., Inc., Rahway, NJ, USA

Beijing, China
Hybrid
Adverse experience report analysis
Pharmacovigilance case management
Regulatory compliance
The Safety Data Lead is responsible for the analysis and interpretation of adverse experience (AE) reports of varying complexity, in compliance with regulatory requirements and internal processes

Job Summary

  • The Safety Data Lead is responsible for the analysis and interpretation of adverse experience (AE) reports of varying complexity, in compliance with regulatory requirements and internal processes.
  • Working under the supervision of a Manager in the Global Pharmacovigilance Case Management (GPVCM), the Safety Data Lead executes AE case management activities for both investigational and marketed products in accordance with specific therapeutic area standards.
  • Collaboration with internal and external stakeholders is essential to maintain high quality and timely execution of the processes.

Matching Summary

The Safety Data Lead is responsible for the analysis and interpretation of adverse experience (AE) reports of varying complexity, in compliance with regulatory requirements and internal processes.

Skills & Requirements

Must-have

  • Adverse experience report analysis
  • Pharmacovigilance case management
  • Regulatory compliance
  • Data entry and interpretation
  • Process standardization

Nice-to-have

  • Clinical knowledge enhancement
  • Stakeholder collaboration
  • Case management optimization
  • Business savviness
  • Networking and partnerships

Key Requirements

  • Bachelor’s degree or above
  • Advanced English writing/reading
  • Intermediate English speaking/listening
  • Understanding of pharmacovigilance regulations

Work Rights

Not specified

Tailored Resume

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