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Salary- Be part of a supportive and stable working environment
- Opportunity for career development
A large global pharmaceutical manufacturer which boasts a good company culture and high retention of staff.
About the opportunity
The Pharmacovigilance Inspection Lead is responsible for the coordination and execution of the company TGA Pharmacovigilance (PV) Inspection Readiness Project.
Duties
- Inspection Readiness Project
- AUS/ NZ affiliate readiness for TGA
- Go through process and identify gaps
- Mock interviews with commercial team / SMEs
- Get everyone ready for inspection
- Sponsors are the GMs and region head for APAC
- Successful candidate will need to lead and run the project
- Successful candidate will need to know what is involved in a TGA inspection
- Quality assurance will provide some support
- The outcome is to ensure readiness for inspection by July
- Adverse event reporting
- Hold weekly meetings with SMEs
- Set up workstreams
- Weekly updates provided to stakeholders/sponsors
- Identify regulations
- Review and identify gaps against TGA requirements
- Document deviations
- Create a storyboard to document any issues
- A degree in Life Sciences is required for this role
- 5+ years experience in a similar role
- Excellent understanding in TGA inspections
- Excellent understanding of TGA requirements and expectations
- Able to lead the commercial side of the business
- Quality experience
Although a large, global company, they are able to provide a family-like culture and prides themselves in developing and upskilling its staff.
Why this opportunity is right for you
This Full-time 6 month contract opportunity is based in Melbourne.
How to Apply
Click apply or contact Rohan Lallbeeharry Senior Recruitment Consultant on 03 9938 7115 for a confidential discussion.
