Job Details
  • Reference381023A_1632857501
  • LocationCanberra
  • Job TypeContract
  • Posted26 days ago
  • ConsultantSharrane Martin

As one of the Australia's largest providers of human resources solutions, Chandler Macleod has a proven track record of unleashing potential in people and companies. For over 40 years Chandler Macleod's recruitment business has connected leading-edge projects and employers with outstanding business professionals.

Our Federal Government client is seeking to engage an APS6 Associate Pharmacovigilance Inspector on a contract for 9 months.

Duties & Responsibilities:

Specific duties include:

  • Contribution to the pharmacovigilance inspection program by:
    • Liaising with sponsors to notify of inspections and coordinate inspection dates, session times and expectations
    • Organising travel bookings (for onsite inspections)
    • Sending document requests to sponsor, as directed by lead inspector
    • TGA data mining to retrieve relevant sponsor data from selected TGA systems
    • Conducting literature review of widely used reference databases such as Medline, Excerpta Medica or Embase
    • Managing documents received from the sponsor before, during and after inspections
    • Filing of documents in records management systems
    • Conducting document review under supervision, as requested by the lead inspector
    • Supporting inspection interview sessions under supervision
    • Assisting the lead inspector with the preparation of timely, high quality inspection reports
    • Distributing inspection reports
    • Liaising with sponsor regarding corrective and preventative action (CAPA) plan
    • Assisting the lead inspector with progressing compliance matters including preparation of briefs for committee consideration, liaising with the legal team, and drafting documents associated with compliance action.
    • Following procedures relating to the inspection close-out
    • Monitoring agreed CAPA commitments
    • Maintaining the PVIP activities tracker and monitor task timelines
  • Developing, with direction from supervisor, new PVIP-related policies, procedures and proposals as required and directed
  • Liaising, engaging and collaborating with internal and external stakeholders to resolve less complex issues/enquiries in relation to compliance with pharmacovigilance legislation, regulations and standards including support to the internal and external forums.
  • Contributing to business improvement and cultural change initiatives
  • Working flexibly in a high pressure environment to achieve team goals and broader organisational objectives by undertaking tasks and managing projects as required and directed.

This position may require interstate travel, for up to 3-4 days at a time, to inspect the pharmacovigilance systems of pharmaceutical companies.

Desirable:

  • Knowledge of the pharmacovigilance landscape in Australia and globally
  • High level critical analytical ability.
  • The ability to support organisational goals.
  • A sound understanding of the regulatory framework for therapeutic goods in Australia, including applicable guidelines, or demonstrated ability to rapidly learn and apply this knowledge.
  • High level written and verbal communication skills.
  • The ability to promote and make balanced decisions that may impact directly on the agency/externally using professional judgement, factoring in risks and being sensitive to context.
  • High level interpersonal, liaison and stakeholder management skills, including the ability to develop productive working relationships to identify opportunities, facilitate cooperation and achieve outcomes.
  • The ability to work flexibly in a high pressure environment while responding positively and flexibly to change and
  • The ability to strategically overcome roadblocks to deliver and drive projects.

Mandatory Requirements:

Candidates must be able to demonstrate:

  • Tertiary qualifications in pharmacy, pharmacology, medicine or relevant biomedical science from an Australian tertiary institution or comparable overseas qualification.

If you feel you are a suitable candidate submit your application by hitting "Apply for this job". Alternatively, you can call Sharrane Martin on 02 6268 9726 or email Sharrane.Martin@chandlermacleod.com for further discussion.