Job Title

Tigermed Sydney, New South Wales, AustraliaPharmacovigilance SpecialistTigermed Sydney, New South Wales, AustraliaResponsibilities:Collaborate and liaise with relevant PV Country Lead and/or Cluster/Area Lead and other GPSE functions to support in the maintenance of appropriate systems/processes to support the local PV system.Provide pharmacovigilance functional support to LOCs where applicable.Support the PV Country Lead and/or Cluster/Area Lead to implement the local PV strategies as appropriate to maintain compliance.Support PV Country Lead and/or Cluster/Area Lead with maintenance of the PV system in the Oceania LOC which can include, but is not limited to compliance to all applicable Global PV processes, commercial team engagements; PSP, MR, suppliers with PV obligations, agreements, supplier issues etc. This includes working with PV suppliers where appropriate and ensuring a common understanding of the distribution of the PV responsibilities is in place.Assist in the preparation of PV training material, ensure planning and implementation of appropriate PV training to sales representative, customer service, investigators and others as appropriate.Work with PV Country Lead and/or Cluster/Area Lead to support in vendor oversight to ensure contracted PV activities meet expected quality and are completed timely.Contribute to safety documents preparation and submission if applicable.Support PV Country Lead and/or Cluster/Area Lead to implement global, regional and local PV strategies at the LOC.Support internal and external PV audits or inspections.Support local PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (incl for business continuity) as required including establishing appropriate oversight of such suppliers, if applicable.Ensure all contact information and any changes of LOC PV personnel are maintained for global communications.Qualifications:Bachelors level degree or above in life sciences, pharmacy, nursing or medical. Advanced degree preferred.2-years or more PV working experience in the pharmaceutical or CRO industry, have a deep understanding of pharmacovigilance and local regulatory requirements and processes for post marketing global.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.Team worker with collaborative approach.Ability to prioritise under pressure.Well-developed organizational skills and high standard of computer literacy.Seniority levelAssociateEmployment typeFull-timeJob functionProject Management, Health Care Provider, and Quality AssuranceIndustriesPharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr