11 Aug
|
AmerisourceBergen
|
North Sydney Council
11 Aug
AmerisourceBergen
North Sydney Council
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Summary:
Responsible for the planning and execution of operational tasks and all aspects of technical delivery and project management in the field of Pharmacovigilance
Manage pharmacovigilance activities according to Local Operating Company/Cluster requirements in Oceania
Act as the Pharmacovigilance Country Lead/Deputy of the Pharmacovigilance Country Lead concerning all Pharmacovigilance activities
Act as National Contact Point or Qualified Pharmacovigilance Qualified in Australia & New Zealand
Collaborate with internal/external key partners, where applicable
Responsibilities:
Ensure compliance with all applicable Global and local Pharmacovigilance processes and regulations
Maintain a constant state of audit and inspection readiness
Support the development and implementation of processes, systems, and tools to manage local Pharmacovigilance activities
Writing/Review of procedural documents such as Working Instructions, Standard Operating Procedures, Working Procedures, Templates etc. for PharmaLex Pharmacovigilance projects
Perform comprehensive safety surveillance and end‑to‑end case management activities, including Adverse Event and Product Quality Complaint handling, follow‑up, Individual Case Safety Report data entry and Quality Control, expedited reporting, mailbox monitoring, reconciliations, preparation of Additional Risk Minimisation Measure/Direct Healthcare Professional Communication materials, completion of metrics/Key Performance Indicators, and provision of pharmaceutical expertise across
📌 Manager Local Pharmacovigilance (North Sydney Council)
🏢 AmerisourceBergen
📍 North Sydney Council