Associate Director, Global Patient Safety Standards & Training
Core
Establish and maintain Pharmacovigilance (PV) procedures and policies to ensure global regulatory compliance and operational efficiency.
Role type
Associate Director, PV Standards & Process Management
Builds
Global PV System, procedural frameworks, and training curricula
Domain
Pharmaceutical/Biotech, Pharmacovigilance, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> dashboards & analysis (metrics on CAPAs, process deviations)
Required skills
Pharmacovigilance regulations, PV Quality Management Systems, procedural update management, PV process design, project management, document management, audit/inspection presentation
Preferred skills
Life sciences education, Data Privacy experience
Technologies
None explicitly listed
Responsibilities
Ensure PV Intelligence updates are reflected in GPS procedures; Act as liaison between Process & Procedures and Learning Centre of Excellence; Partner with Head of GPS Safety Operations to validate procedures; 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 Planned Process Deviations (PPDs); Coordinate CAPA closure and training alignment; Provide metrics on process performance; Lead initiatives to enhance process effectiveness; Represent Standards & Training in audits and inspections.
Seniority
Senior, hands-on IC with strategic oversight
