Senior Director, Safety Officer China

Bion Environmental Technologies Inc

Shanghai, China
On-site
Chinese safety and pharmcovigilance requirements
Patient safety and pharmacovigilance matters
Local health authority review boards
Work in close partnership with global and local MSPv team member and cross-functional teams across clinical development, regulatory affairs , Quality and future commercial related teams to ensure compliance to Chinese safety and pharmcovigilance requirements

Job Summary

  • Work in close partnership with global and local MSPv team member and cross-functional teams across clinical development, regulatory affairs , Quality and future commercial related teams to ensure compliance to Chinese safety and pharmcovigilance requirements.
  • Serve as the primary point of contact for senior cross-functional leaders locally and globally on matters related to patient safety and all Pharmacovigilance matters for China.
  • Drive the talent agenda: Leading people processes through recruitment, training, coaching and performance to meet all business requirements sustaining both global and local competitiveness and diversity.

Matching Summary

Work in close partnership with global and local MSPv team member and cross-functional teams across clinical development, regulatory affairs , Quality and future commercial related teams to ensure compliance to Chinese safety and pharmcovigilance requirements.

Skills & Requirements

Must-have

  • Chinese safety and pharmcovigilance requirements
  • patient safety and Pharmacovigilance matters
  • local Health Authority review boards
  • local pharmacovigilance-related procedural documents
  • company quality procedures and standards
  • local audits and inspections
  • Vendor and Partner Management

Nice-to-have

  • cross-cultural experience
  • fast-paced start-up environment
  • high degree of autonomy
  • ability to manage ambiguity

Key Requirements

  • Master's Degree or similar
  • 15+ years of experience in pharmacovigilance
  • PV head experience preferred
  • Expert knowledge of pharmacovigilance regulatory requirements in China
  • Experience in clinical trial safety management
  • Fulfillment of local safety officer responsibilities
  • Fluent in written and spoken English language

Work Rights

Not specified

Tailored Resume

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