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Job Details
- Location
- Shanghai
- Salary
- Competitive Salary
- Job Type
- Permanent
- Ref
- BH-17782
- Contact
- Yin Yin Pui
- Contact email
- Email Yin
- Contact phone
- +65 6692 0751
- Posted
- about 1 month ago
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
BeathChapman Pte Ltd
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