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Vertex is seeking a qualified PV professional to build and manage its global Pharmacovigilance structure, ensuring adherence to international regulations. The role includes coordinating local PV Responsible Persons and reviewing regulatory intelligence to support safe product operations.
Responsibilities span SOP/WI development, vendor oversight, and enabling geographic expansion. The candidate will liaise across functions, provide PV guidance to teams, and help maintain robust PV processes in a
Role: Support build-out and management of Vertex's global Pharmacovigilance (PV) structure, ensuring compliance with international PV regulations.
Responsibilities include oversight of local Responsible Persons for PV, review and assessment of global PV regulatory intelligence, development of PV agreements, and supporting geographic expansion initiatives. The role involves reviewing SOPs, WIs, and acting as a liaison for safety issues, fostering cross-functional relationships, and providing PV guidance across teams.
Requirements: B.S. or PharmD/M.S.N with 3-5 years of PV-related experience; proficiency in Microsoft Office; knowledge of global PV regulations.
High-Value: PV compliance, regulatory intelligence, SOP/WI development, global PV operations, vendor oversight, cross-functional collaboration, and supporting international geographic expansion.
Work setup: Remote-Eligible, with flexible options; travel not specified.