Primary responsibility for overseeing all Pharmacovigilance (PV) and Regulatory reporting program management related activities for assigned clients, including, but not limited to, serving as primary customer interface, managing and fulfilling client expectations and overseeing internal program management activities and teams.
Work closely with and advise Medical Information (MI) functional area management and team members in a collaborative and cross-functional setting. Responsibilities encompass the overall PV management of assigned projects/products/staff, including budgeting, scope, timeline adherence, internal and external communications, and project deliverables.
Ensure that PV functional area personnel assess and process adverse event reports according to appropriate regulations, SOPs, Good Pharmacovigilance Practices, Good Clinical Practices, and client specific procedures.
Works with or le
Valid through: 2020-2-19