Pharmacovigilance Specialist

539

Macquarie Park, NSW, Australia
Competitive remuneration; not specified; competiti...
Hybrid
Ae case lifecycle management
Literature screening and health authority monitoring
Pv audit and inspection support
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; Not specified; competitive benefits

Skills & Requirements

Must-have

  • AE case lifecycle management
  • literature screening and Health Authority monitoring
  • PV audit and inspection support
  • local PV agreement management
  • PV controlled documents and training materials
  • safety and regulatory documentation archiving

Nice-to-have

  • drive process improvements
  • collaborative team culture
  • respectfully challenge thinking
  • inclusive environment

Key Requirements

  • Health, life science, or medical science degree
  • Pharmaceutical industry experience preferred
  • General knowledge of AE reporting and PV regulations preferred
  • Fluency in English (written and spoken)
  • Proficiency in the local language

Work Rights

Not specified

Tailored Resume

Cover Letter