China Sr. PV scientist
Posted on: 09/10/2026
Shanghai,Beijing East China
Permanent
Pharmaceutical and Healthcare
China NDA & Regulatory Support
Required
- Serve as the key PV contact for China NDA-related activities.
- Support preparation, review, and response to NMPA/CDE safety-related questions and information requests during the NDA review process.
- Provide PV input to China regulatory submissions, safety documents, risk management activities, and regulatory commitments.
- Monitor changes in China PV regulations and communicate relevant requirements to the Global PV team.
- Support preparation for potential NMPA/CDE PV inspections and audits.
- Support the establishment and maintenance of the Company's China post-marketing PV system and safety surveillance activities following product approval.
- Coordinate the collection, intake, documentation, and follow-up of adverse event (AE) and serious adverse event (SAE) reports from Mainland China.
- Review and assess safety information and ensure appropriate medical assessment, documentation, escalation, and follow-up.
- Ensure reportable Individual Case Safety Reports (ICSRs) from China are submitted to the global safety database within required timelines.
- Work with the Global PV team and external PV service providers to ensure timely and accurate case processing, follow-up, reconciliation, and reporting.
- Support ongoing review of China safety data and identification, assessment, and escalation of potential safety signals.
- Provide China-specific safety information and input to PBRERs/PSURs, DSURs, RMPs, signal evaluations, and other aggregate safety activities, as applicable.
- Ensure China PV activities are conducted in compliance with applicable NMPA/CDE requirements, GVP, and company procedures.
- Maintain appropriate documentation and records for China PV activities.
- Collaborate with China Regulatory, Medical, Clinical, Quality, and other functions on safety-related matters.
- Serve as the liaison between the China organization and Global Pharmacovigilance.
- Provide PV training and guidance to relevant China-based personnel and business partners regarding AE/SAE reporting requirements.
Required
- MD, PharmD, or equivalent medical/pharmaceutical/scientific degree.
- 5+ years of relevant experience in pharmacovigilance, drug safety, clinical safety, or a related pharmaceutical function.
- Strong understanding and practical experience with China/NMPA/CDE pharmacovigilance requirements.
- Experience with AE/SAE assessment, ICSR case management, follow-up, and safety reporting.
- Experience supporting regulatory submissions and/or responding to regulatory safety questions.
- Understanding of China post-marketing pharmacovigilance and safety surveillance requirements.
- Familiarity with global PV principles and international regulatory requirements.
- Excellent Mandarin and English written and verbal communication skills.
- Strong organizational skills, attention to detail, and ability to manage regulatory timelines and multiple priorities.
- Experience supporting a China NDA submission and/or NMPA/CDE regulatory review for a new pharmaceutical product.
- Experience establishing or managing China post-marketing PV activities.
- Experience with a global safety database such as Oracle Argus.
- Experience with signal detection, aggregate safety reporting, RMPs, PBRERs/PSURs, or DSURs.
- Experience supporting PV audits or regulatory inspections.
- Experience in a multinational pharmaceutical or biotechnology company.
- Experience in rare disease, ophthalmology, or innovative pharmaceutical products is a plus.
- Strong medical and scientific judgment
- Solid knowledge of China PV regulations and regulatory practices
- Strong attention to detail and data quality
- Effective communication and cross-functional collaboration
- Ability to identify, assess, and appropriately escalate safety issues
- Proactive, independent, and solution-oriented approach
- Strong commitment to patient safety and regulatory compliance