Patient Safety Associate - 14-month contract
Core
Manage Individual Case Safety Reports (ICSRs) and Safety Issue reporting to ensure regulatory compliance and patient safety for medicines across Australia and New Zealand.
Role type
Pharmacovigilance Associate (ICSR Management)
Builds
Local pharmacovigilance system and regulatory reporting processes
Domain
Healthcare / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICSR management, pharmacology knowledge, safety information assessment, regulatory compliance, audit readiness, Risk Management Plan (RMP) support, Product Information (PI) and Consumer Medicine Information (CMI) development
Preferred skills
Healthcare professional background (pharmacist), literature monitoring, digital channel screening, process improvement
Technologies
None stated
Responsibilities
Execute ICSR management processes, drive continuous improvement in case management, manage Safety Issue reporting, support audit and inspection readiness, collaborate on Risk Management Plans, prepare Australian-specific RMP annexes
Seniority
Mid-level, hands-on IC
