Senior Director, Safety Officer China

Senior Director, Safety Officer China - responsible for ensuring compliance to Chinese safety and pharmacovigilance requirements, working closely with cross-functional teams and providing guidance on developing comprehensive safety deliverables.

Requirements

• Master's Degree or similar degree in Medical (MD or equivalent), Life Science or Pharmacy
• 15+ years of all-round experience in pharmacovigilance and product safety within the pharmaceutical industry, biotech or CRO
• Strong understanding of the drug development and drug licensing process
• Expert knowledge of pharmacovigilance regulatory requirements in China and good understanding of global regulatory requirements
• Experience in clinical trial safety management (e.g. including but not limited to case processing and signal detection process) according to ICH standards and local requirements
• Experience in managing the local pharmacovigilance system, including but not limited to case handling and pharmacovigilance documentation
• Fulfillment of local safety officer responsibilities
• Experience in preparing for and responding to regulatory audits and inspections
• Experience in Vendor and Partner Management
• Fluent in written and spoken English language
• Experienced with formal regulatory and legal language documents
• Strong leadership and cross-cultural experience
• Strong problem-solving and decision-making skills in relation to working in a fast-paced start-up environment
• High degree of autonomy
• Ability to manage ambiguity and operate effectively
• Self-starter, ability to flex and change direction as business needs necessitate

Benefits

• Competitive remuneration packages
• Variety of benefits in support of diverse employee base