Associate Director, Global Patient Safety Standards & Training
Core
Establish and maintain Pharmacovigilance (PV) procedures and policies to ensure regulatory compliance and operational efficiency across global territories.
Role type
Senior IC Associate Director, Pharmacovigilance Standards & Training
Builds
Global PV System, procedural frameworks, and training curricula
Domain
Pharmaceutical/Biotech, Pharmacovigilance, Regulatory Affairs
Required skills
Pharmacovigilance regulations, PV Quality Management Systems, procedural design, process optimization, project management, document management, audit/inspection presentation, cross-functional collaboration
Preferred skills
Life sciences education, Data Privacy
Technologies
None stated
Responsibilities
Ensure PV Intelligence updates are reflected in GPS procedures; Act as liaison between Process & Procedures and Learning Centre of Excellence; Partner with Safety Operations to validate procedures against safety practices; Develop and maintain GPS procedures in alignment with regulations; Set risk-based prioritization for procedural updates; Manage content of procedures and PSMF Annex E; Maintain oversight of CAPAs and process deviations; Provide metrics on compliance and process performance; Lead initiatives to enhance process effectiveness; Represent Standards & Training in audits and inspections.
Seniority
Senior, hands-on IC