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Pharmacovigilance Expert

3 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $90,000 - $120,000
Job Opportunity

We are seeking a skilled Pharmacovigilance Professional to join our team.

The ideal candidate will be responsible for the following key areas:

  1. Liaising with PV Country Lead and/or Cluster/Area Lead to maintain appropriate systems/processes for local PV system.
  2. Providing pharmacovigilance functional support to LOCs where applicable.
  3. Implementing local PV strategies under the guidance of PV Country Lead and/or Cluster/Area Lead to ensure compliance.
  4. Maintaining the PV system in Oceania LOC, including compliance to Global PV processes, commercial team engagements, PSP, MR, suppliers with PV obligations, agreements, supplier issues etc.
  5. Preparing PV training material and ensuring planning and implementation of PV training to sales representative, customer service, investigators and others as appropriate.
  6. Supporting vendor oversight to ensure contracted PV activities meet expected quality and are completed timely.
  7. Contributing to safety documents preparation and submission if applicable.
  8. Implementing global, regional and local PV strategies at the LOC.
  9. Supporting internal and external PV audits or inspections.

To be successful in this role, you will require:

  • A Bachelor's level degree or above in life sciences, pharmacy, nursing or medical. An advanced degree is preferred.
  • At least 2 years of experience in PV working in the pharmaceutical or CRO industry, with a deep understanding of pharmacovigilance and local regulatory requirements and processes for post marketing global.
  • An understanding of medical/scientific terminology.
  • Excellent written/oral communication skills (local language and English) and experience working with internal and external stakeholders.
  • Accuracy and attention to detail with flexible mindset.
  • A collaborative approach with ability to prioritize under pressure.
  • Well-developed organizational skills and high standard of computer literacy.