Sr. Patient Safety Specialist
Core
Maintain local Pharmacovigilance (PV) systems, govern patient safety procedures, and ensure compliance with health authority regulations and Good Pharmacovigilance Practice (GVP).
Role type
Senior Individual Contributor Patient Safety Specialist
Builds
Local PV systems, regulatory submissions, and safety governance frameworks
Domain
Life Sciences / Pharmacovigilance
Required skills
Pharmacovigilance regulations, ICSR processing, Risk Management Plans (RMP), Health Authority interactions, CAPA management, Vendor oversight, Data reconciliation, Training delivery
Preferred skills
Advanced operational oversight, Cross-functional collaboration, Analytics and reporting tools, Business Continuity Planning
Technologies
Argus, Orbit, MyTime Portal, VQV, Cover, ERV, Veeva CRM, ECMS, Digital Assets Portal, PAL, Learning Management System
Responsibilities
Maintain local PV system compliance and inspection readiness; Oversee ICSR processing and submission to health authorities; Manage local Risk Management Plans (RMP) and risk minimization activities; Lead or mentor local PS staff and support continuous improvement initiatives; Support audit readiness and manage corrective and preventive actions (CAPA).
Seniority
Senior, hands-on IC
