Leads ICSR and aggregate report compliance monitoring, risk management activities and assessing Pharmacovigilance processes for consistency and compliance with global/local laws and regulatory requirements.
Collecting and evaluating safety management information such as ADRs or infection cases and reporting to authorities. （Evaluating safety management information, preparing reports, submitting to authorities, maintaining data base and archiving records）
Supports the continued development and maintenance of standard metrics / key performance indicators that reflect the effectiveness of the compliance program and help facilitate identification process gaps related to reporting, metrics, and trending to maintain compliance.
Assists with management of routine internal safety review for updates and evaluation of business to ensure adherence.
Reviews/writes procedures, deviations and CAPA plans and tracks progress to ensure completion. Sustains consistent evaluation of PV processes for improvement to efficiency, accuracy and compliance.
Provides operational and logistical lead of internal and external audits as well as regulatory inspections
Participates in and organizes Inspection Readiness activities
Communicates and collaborates with Pharmacovigilance team and cross－functional teams as necessary throughout the organization to optimize Pharmacovigilance departmental quality and compliance.
Coordinates PV administration of training records, tracking and curriculum.
Prepares written reports and training material and present as required to internal stakeholders.
Lead archiving all the documents which are defined to be stored by GVP/GPSP
Negotiate with MHLW/PMDA
Lead exchanging safety agreement with business partners
Prepare / revise of GVP/GPSP/GCP SOP and relevant SOP
Lead labeling, implementing and monitoring risk minimization measures as necessary for products and the planning and implementing safety measures such as information dissemination
Responsible for other duties as assigned
【必須（MUST）】More than 3 years’ experience in drug safety role in pharmaceutical industry