Vivan Tran

Background

About Vivan Tran

16 years of industry experience, 14 years in Drug Safety and Pharmacovigilance.• Built PV Operations and Compliance departments. Head of PV Operations and Lead PVQ• Instructor for SJSU Master’s program on the Fundamentals of Drug Safety and Pharmacovigilance (DSP). Created course curriculum, lecture slides, and assignments on the importance of DSP in their careers and outside of their careers. • Outstanding knowledge in drug safety and pharmacovigilance (PV) with clinical trials and post marketing case processing and workflow process.• Participated in PV compliance audit/inspections by providing assistance in the back room and front room. • Experienced in safety databases (Argus and Arisg).• Executed SDEAs/PVAs• Diverse vendor management skills developed through managing partnerships with PV case processing vendor, safety database vendors, and business partners. • Authored and maintained SOPs and work instructions for drug safety and pharmacovigilance procedures.• Participated in cross-functional team collaborations with Drug Safety, Regulatory Affairs, Clinical Operations, Biostats, and Data Management, to achieve project goals. • Extensive project management skills to manage multiple projects within stringent timelines and quality standards for Pharmacovigilance Operations. • Lead trainer to provide Argus and Pharmacovigilance web portal training for global and domestic vendors.• Conducts adverse events reporting under GCP and local regulations, including FDA 21 CFR 312 and ICH guidelines. • Extensive project management skills to manage multiple projects within stringent timelines and quality standards for PV Operations• Strong people leadership skills• Demonstrates strong public speaking skills. • Proficient with the Microsoft Office Suite. • Motivated to work in a team and capable of working independently.