Pharmacovigilance Specialist

Laboratory Animal Management Association

Macquarie Park, NSW, Australia
Competitive remuneration + benefits
Hybrid
Ae case lifecycle management
Literature screening and health authority monitoring
Pv controlled documents and training materials
Take ownership of delegated PV tasks with minimal supervision, from case intake and ICSR/aggregate submissions to compliance monitoring, local PV agreement management, audit support, training and archiving

Job Summary

  • Take ownership of delegated PV tasks with minimal supervision, from case intake and ICSR/aggregate submissions to compliance monitoring, local PV agreement management, audit support, training and archiving.
  • Execute local pharmacovigilance processes and collaborate with internal teams and external partners as assigned.
  • Work autonomously with strong support and mentorship within a trusted global pharmaceutical organisation.

Matching Summary

Take ownership of delegated PV tasks with minimal supervision, from case intake and ICSR/aggregate submissions to compliance monitoring, local PV agreement management, audit support, training and archiving.

Salary

competitive remuneration and benefits

Skills & Requirements

Must-have

  • AE case lifecycle management
  • literature screening and Health Authority monitoring
  • PV controlled documents and training materials
  • PV self-inspections and compliance corrective actions
  • independent QC of selected PV activities
  • Fluency in English

Nice-to-have

  • drive process improvements
  • collaborative team culture
  • work autonomously with support
  • flexible working arrangements

Key Requirements

  • Health, life science, or medical science degree
  • Pharmaceutical industry experience preferred
  • General knowledge of AE reporting and PV regulations preferred

Work Rights

Not specified

Tailored Resume

Cover Letter