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