Summary
Oversees operational delivery and staff within Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements. Interacts with and provides guidance to internal functions and external vendors as required for seamless GPS Operations
Responsibilities
- Oversee and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting
- Coordinates with and supports deliverables with GPS GSL team in relations to case processing
- Collaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processes
- Communicate with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA).
- Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication
- Proactively identifies issues and areas for improvement and escalates appropriately
- Proactively engages in the development of new processes and procedures and leads implementation of those
- Performs all activities in compliance with applicable Controlled Procedures and with global and local regulations as applicable.
- Perform other tasks as assigned by line manager or head of GPS
Requirements
- Bachelor's / Master's degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
- Minimum of 5 years of relevant experience in Safety / Clinical Research / Pharmacovigilance
- At least 7 years of relevant experience in global pharmacovigilance/drug safety (EU&US)
- Equivalent and adequate combination of education and experience
- Advanced expertise of global (EU/US) pharmacovigilance requirements and practices
- Advanced experience with safety database systems (ARGUS a plus) including workflow management
- Proven experience in interaction with 3rd party vendors
- Proven experience with the identification of quality issues and evaluation of quality metrics
Kang Abelene Marianne Mrs Rozario Abelene Marianne
EA License No.: 02C3423 | Personnel Reg No.: R2089914
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