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Location
上海
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-17782
Contact
Yin Yin Pui
Contact email
Email Yin
Contact phone
+65 6692 0751
Posted
10ヶ月前
Location: Shanghai / Beijing, China
Industry: RNAi Therapeutic Biotech


Responsibilities:

  • Monitor safety data for assigned therapeutic projects in (pre-market) clinical stages; review adverse event reports including SAEs (serious adverse events) and unexpected events
  • Proactively identify safety signals, conduct benefit-risk assessments using safety data and literature available
  • Ensure accurate safety data entry in pharmacovigilance databases, assist in safety report preparation
  • Stay updated on global regulations landscape, collaborate with regulatory teams to ensure timely safety document submissions
  • Support cross-departments collaboration on patient safety reviews and related projects.
 

Qualifications:

  • Clinical Medicine degree (MD)
  • 5 years prior experience in handling PV or patient safety in pharma / biopharma industry
  • Familiar with regulatory guidelines (e.g. MAH, ICH, NMPA, FDA, etc.)
  • Effective communicator with excellent analytical skills



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