Responsibility:

• Demonstrates knowledge in pharmacovigilance (PV) which includes an understanding of relevant aspects of applicable laws, regulations and guidances.

• Performs initial review of the adverse event to assess seriousness and relatedness and follow up SAE queries to investigator sites or reporter(s).

• Ensures all the SAEs are submitted to China Health Authority as per China Regulations and notifies investigators in timely manners.

• Provides consultation, preparation, and maintenance of the safety sections of Clinical Trial protocols, study reports and other relevant documents.

• Closely monitor the safety data of HBM’s compounds/products during the life cycles by reviewing adverse events periodically (individual case safety reports and aggregated safety data) and prepare relevant safety documents as per Regulations request, such as, RMP, DSUR.

• Builds collaborative working relationships with cross-functions and vendors to fulfill safety obligations and high-quality medical evaluation of safety data.

• Provide safety training to HBM staffs and investigators to ensure PV compliance.

• Keep alert on inspection requirement and provide support if appreciated.
  

  
  

Key competencies required:

• Familiar with China PV Regulations, GVP guidance and ICH guidance;

• Drug development and pharmacovigilance knowledge;

• Excellent interpersonal, organizational, negotiation skills and teamwork;

• Self-motivation;

• Insightful;

• Creative.

Other requirements:

• Major in medical or pharmacy, bachelor degree or above;

• At least 3 years working experience including clinical practice and pharmacovigilance or other drug development experience;

• Fluent English in speaking, reading and writing.

上班地址：上海张江哈雷路866号