>>>Location：Shanghai
【Responsibilities】
·Manage safety database and ensuring that the safety database and associated tools are maintained in a validated state;
a).Setup and complete the validation with the cooperation of safety database vendor;
b).Complete the E2B gateway test with regulatory authorities’ safety database;
c).Management of change requests submitted by users;
d).Maintenance of the database configuration;.
e).Leading migration of data from other safety databases;
f.Provide user training to internal users and CRO partners;
g).Design and production of standard and specialised reports to ensure meeting regulatoryrequirements and company objectives, and to support patient safety;
h).Develop safety database relavant SOP/WI;
i).Upgrade the safety database.
·Product safety management, and the core job responsibilities may include those listed below:
a).Study level documents review from PV perspective, e.g., CSP, SAP, CRF, CSR.
b).Product level documents review from PV perspective, e.g., IB.
c).Develop RCP, DSUR, SMP, RMP, etc. or review them when outsourced.
d).Identify and investigate safety signals.
e).Provide PV support on publication, IND and NDA.
·Oversight the AE Processing that may includes the activities below:
a).To collect, process and follow up all local adverse events (AEs) from different sources(Healthcare professionals, CRO, patients, etc.)
b).To report the AEs to the HA according to the Chinese regulation within the required timeframe.
c).To answer the safety questions from the Health Care Professionals with the support of Medical
department.
d).To archive all source documentation in accordance with standard operating procedures
e).To maintain a record of Pharmacovigilance source documents and keep them available on request by the HA
·Draft and update PV agreement with partners.
·Develop and update PV relevant SOPs/WIs.
·PV vendor management
【Qualification】
·Master degree in clinical medicine or pharmacy, oncology related therapeutic area is a plus.
·Safety database management experience is mandatory.
·Familiar with the relevant regulations, with experience in pharmacovigilance.
·At least 3+ years of pharmaceutical industry (clinical research, pharmacovigilance, or medical affairs), or equivalent with a minimum 3+ years in clinical area (physician etc.).
·PV Vendor management experience is a plus.
·Good communication, team management and hands on.
>>>Contact Information：
Contact Person：Frank Wang
Mobile：15680922101
Mail：frank.wang@isaac-kenneth.com
