Associate Director, Global Patient Safety Standards & Training
Core
Establish and maintain Pharmacovigilance (PV) procedures and policies to ensure regulatory compliance and operational efficiency globally.
Role type
Associate Director, PV Standards & Training
Builds
Global PV System and associated training curriculum
Domain
Pharmaceutical/Biotech, Pharmacovigilance, Quality Assurance
Required skills
Pharmacovigilance regulations, PV Quality Management Systems, procedural design, project management, document management, audit/inspection experience, cross-functional collaboration
Preferred skills
Life sciences education, Data Privacy experience
Technologies
None stated
Responsibilities
Ensure PV Intelligence updates are reflected in GPS procedures; Act as liaison between Process & Procedures and Learning Centre of Excellence; Validate procedures against safety practices and map to regulations; Develop and maintain GPS procedures in alignment with global regulations; Manage content of procedures and PSMF Annex E; Maintain oversight of Planned Process Deviations (PPDs); Coordinate CAPA closure related to procedures; Provide metrics on process deviations and training compliance; Lead initiatives to enhance process effectiveness; Represent Standards & Training in audits and inspections.
Seniority
Senior, hands-on IC
