·Review and analyze patient safety data from clinical trials to identify and investigate safety signals; manage ongoing benefit and risk profile.
·Accountable for all PV activities associated with filing and approval of clinical and marketing applications under line manager' supervision:
Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and by regulatory authorities,
Manage safety surveillance and data collection, in cooperation with a PV vendor, of current trials for safety signaling,
Provides review of vendor activities include monitoring compliance, effective communication
and implementation of corrective and preventive actions, as needed
Conduct analysis of safety data to ensure adequacy of recording, summarizing, and handling of adverse events for investigational products including decisions on seriousness, expectedness, and causality.
Contribute to the development and implementation of risk minimization action plans.
Provide support on clinical safety content of IND/NDA filing (e.g. IND Risk Control Plan, NDA
Clinical Safety Summary and Risk Management Plan）
·Accountable for medical review of ICSRS from all sources.
·Responsible for responses to inquiries from regulatory authorities or HCPS on safety issues.
·Work with clinical programs as medical advisor to provide safety support for clinical development programs/plans.
·Maintain PV quality and develop/update PV SOPS/training programs as necessary.
·Responsible for managing cross-functional activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across clinical trials.
·Maintains knowledge of adverse event reporting process and safety system and contributes to the development.
·MD degree, clinical medicine related major required, overseas background (studying or working preferred.
·Minimum 5 years in pharmaceutical industry (pharmacovigilance, or medical affairs or clinical research)or equivalent with a minimum 3 years in direct pharmacovigilance and/or drug safety.
·Previous experience reviewing or contributing to PSUR and other safety surveillance reports.
·PV Vendor management experience is a plus.
·Knowledge of NMPA, FDA, ICH Regulations and Requirements for Pharmacovigilance.
·Argus, ARISG or other Safety Database experience.