Associate Pharmacovigilance Inspector
Background information on Section and Branch
The Branch is responsible for undertaking post-market monitoring of medicines and vaccines to ensure that they continue to maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace. Branch functions also include the pharmacovigilance inspection program, and the evaluation and monitoring of Risk Management Plans for high-risk medicines.
Domestic travel required for the role
Yes – This position may require interstate travel, for up to 3-4 days at a time, to inspect the pharmacovigilance systems of pharmaceutical companies.
30 June 2022
Full-time (37.5 Hours per Week) preferred
Part time or flexible working arrangements may be considered or negotiated depending on the strengths of the applicant.
Canberra – Symonston Campus
Sydney – Paramatta office
Duties of position Specific duties include:
- 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
- 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
- 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.
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.
- 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.
If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
0403 200 666
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