Eli Agassi

Broad Pharmacovigilance experience including leading complex Pharmacovigilance projects and teams, and managing the intake and submission of safety information of ICSRs and Periodic Reports for pre-marketing and post-marketing portfolios. Developing and implementing safety management plans. Vendor/client management, PV agreement, monitoring compliance, PV operations, and cross-functional collaboration. Easily adapt to changes in priorities and manage multiple assignments simultaneously. Solution-focused with excellent communication skills. Experience & Knowledge includes: - Vaccines, drugs, OTC, and medical device - Safety regulations and guidance of FDA, Health Canada, EMA, and ICH - Safety management for clinical trials and post-approvals - Submission of safety information of Per...