Askari Jacques Email & Phone Number

New Jersey, United States

 Monitors case processing workflow and performs quality control management of work performed within the safety database internally or by PV vendor. Supports in the safety database administration for the Pharmacovigilance department.o Performs system administrative task as needed under supervision.o Supports in the registration in and configuration of safety system.o Performs E2B testing with required Health Authorities to obtain certification.o Supports testing and validation of safety database/system updates and upgrades. Develops safety system training materials and delivers training to both employees and PV vendor. Provides all necessary listings for aggregate reports, signal detection, monthly safety data review, GSPC, etc.  Supports the safety data management activities and all information systems owned by TOI pharmacovigilance.  Assesses improving safety systems to effectively use technology-enabled process solutions. Assists in business integration including safety data migration and integrating new assets or companies into Taiho PV system. Provides oversight of all PV mailboxes. Oversees all safety data submissions and exchanges with Health Authority and TOI business partners. Imports cases that are received from business partners and Health Authorities, and performs workflow management. Contributes to new or revision of SOPs, work instructions, guidance in regards pharmacovigilance technological systems. Performs and oversees SAE reconciliation between clinical and safety databases and case processing as a result of SAE reconciliation. Provides needed information to PV Quality Management System. Ensures inspection readiness of pharmacovigilance safety database. Establishes good communication and fosters relationships with all stakeholders including TPC, PV Vendors, and TOI business partners on all pharmacovigilance related issues. Supports