Responsibilities:
1 Oversee the safety management of assigned products throughout their lifecycle
2 Conduct safety surveillance and signal detection activities
3 Contribute to the development and implementation of risk management plans
4 Provide technical input and expertise during safety reviews and relevant documents (e.g., protocol, IB, ICF, CSR, labelling) review
5 Collaborate with cross-functional teams to review and interpret safety data for regulatory submissions and/or partner cooperation
6 Conduct medical assessment of individual case safety reports and contribute to safety aggregate reports (e.g., DSUR, PSUR/PBRER)
7 Monitor and communicate emerging safety concerns and trends to internal and external stakeholders
8 Participate in safety-related regulatory interactions and support regulatory inspections and audits
9 Collaborate with cross-functional teams to ensure safety information is effectively communicated to stakeholders
10 Stay updated with the latest developments and regulations related to drug safety

Requirements:
1 Medical degree
2 Minimum of 3 years of experience in pharmacovigilance or drug safety, preferably in the oncology therapeutic area
3 Strong knowledge of pharmacovigilance practices, global and local regulations
4 Good understanding of drug development and clinical study
5 Experience in safety evaluation of adverse events and signal detection
6 Familiarity with risk management plans and safety aggregate reports
7 Effective communication and collaboration skills to work with cross-functional teams and partners
8 Ability to analyze and interpret complex safety data
9 Proficiency in both written and spoken Chinese and English languages
10 Able to work independently and prioritize tasks effectively