Clinical Expert

331825BR
Jan 20, 2022
Australia

Job Description

800! Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world.

Ensures adherence to Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GpvP) standards in Australian and New Zealand. In particular, assist Development QA Manager in assuring the quality and compliance of Novartis sponsored local and global clinical trials, as well as Investigator Initiated Trials (IITs) and research collaborations. You also assist with quality and compliance activities related to pharmacovigilance.

Your Responsibilities:

Your responsibilities include, but not limited to:

• Escalate, investigate, track and follow up on Process Deviations/Quality Issues across clinical, pharmacovigilance and other medical or commercial groups using the Novartis quality management system.
• Prepare Deviation’/Quality Issue, Quality Event and Action summary and status reports monthly for Dev QA Manager for presentation at quarterly Country Quality Review Board meetings.
• Monthly compilation and reporting of global Key Quality Indicators (KQIs}, monitor and assure that gaps are addressed appropriately in order to mitigate risk.
• Provide support prior to, during and after Novartis global audits of the country organisation, investigational sites or external service providers/license partners, as applicable
• Ensure country readiness for all GxP regulatory inspections. Provide support prior to, during and after HA inspections of the country organisation, investigational sites or external service providers, as applicable, together with the Novartis inspection lead.
• Ensure documentation and management of local corrective and preventive actions (CAPA) to support appropriate review and closure. Assure local line functions take appropriate ownership of duties as required by the CAPA processes.
• Execution of QA activities required for the qualification/requalification of ESPs supporting activities with a clinical/medical or pharmacovigilance component (including Patient Oriented Programs)
• Support and monitor implementation of the local Quality Plan (QP) deliverables related to GCP and pharmacovigilance areas

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• Degree in Life Sciences or related fields
• Minimum 5 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance or a directly related area. Preferably minimum of 3 years’ experience in clinical development (executing/managing clinical trials e.g. Snr CRA/CSM/Project Manager)
• Strong project management and people management skills
• High organized and detailed oriented

Why consider Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, colour, religion, gender, national origin, age, sexual orientation, marital or veteran status or disability.
Global Drug Development
QA GDD
Australia
Sydney
Quality
Full Time
Regular
No
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331825BR

Clinical Expert

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