Overview
Position Summary:
We are seeking a qualified Drug Safety Physician to support our client in China on a part-time, remote contract basis.
The selected candidate will be responsible for providing medical oversight and expertise in pharmacovigilance activities, including case review, signal detection, and regulatory compliance. This role requires strong experience in drug safety within a pharmaceutical setting and a solid understanding of China pharmacovigilance regulations.
Key Responsibilities:
- Perform medical review of ICSRs, ensuring clinical accuracy, completeness, and regulatory compliance
- Provide medical assessment of adverse events, including causality evaluation and signal identification
- Support aggregate reports (PSURs, DSURs, signal reports) with medical input and review
- Act as a medical expert for safety queries, supporting PV and cross-functional teams
- Contribute to risk management activities, including RMP review and safety strategy
- Ensure compliance with China PV regulations (NMPA) and global pharmacovigilance standards
- Support health authority interactions and respond to safety-related queries
- Participate in signal detection and benefit-risk evaluation
- Provide input into safety sections of clinical and regulatory documents
- Collaborate with global and local stakeholders including PV, Regulatory, and Clinical teams
Qualification & Profile:
- MD (Physician) – mandatory
- 5–8 years of experience in pharmacovigilance / drug safety
- Demonstrated experience in medical review of ICSRs, signal detection, and aggregate reporting
- Good knowledge of China pharmacovigilance regulations (NMPA)
- Prior experience within pharmaceutical drug safety teams
- Fluent in English and Chinese
- Strong analytical, communication, and collaboration skills
