Compliance & Pharmacovigilance Manager

Benefits
• Join an organisation truly passionate about patients lives
• Opportunity to contribute to cutting-edge medical advancements
• Engage with a collaborative and innovative team
• Competitive salary package and an opportunity to make a meaningful impact

About the Company
Our client is a leading global pharmaceutical company specialising in breakthrough solutions with the well-being of patients being a primary focus. With a strong presence in Australia, they are dedicated to improving patient care and outcomes through innovation and collaboration.

About the Opportunity
In this pivotal role, you will spearhead compliance, and pharmacovigilance initiatives, ensuring the highest standards of data security and regulatory adherence. Reporting to key stakeholders, you will play a vital role in our client's success, shaping their impact on the pharmaceutical market and reinforcing their commitment to patient well-being.

Duties
• Oversee the pharmacovigilance function to maintain compliance with local and global Pharmacovigilance requirements within Australia and New Zealand.
• Collaborate with the team to implement necessary updates to Pharmacovigilance systems, aligning them with global requirements.
• Take charge of compliance oversight by performing gap analyses and proactive audits to identify weaknesses and areas for development.
• Develop, maintain, and review local Policies, Standard Operating Procedures (SOPs), and Working Practices.
• Ensure compliance with relevant legislation and stay up-to-date with emerging best practices.
• Conduct thorough investigations into compliance and privacy incidents
• Take charge of compliance oversight by performing gap analyses and proactive audits to identify weaknesses and areas for development.
• Monitor and ensure adherence to internal processes, as well as applicable Codes and regulations, through regular and ad-hoc controls.
• Educate and train employees and external collaborators on these processes, regulations, and industry practices.
• Participate in the review of promotional, marketing, and educational materials to guarantee alignment with regulations and industry standards.
• Ensure meticulous documentation practices and maintain comprehensive training records. Manage and record deviations and Corrective and Preventive Action (CAPA) plans as required.

Skills and Experience
• Hold a Bachelor's degree at a minimum, preferably in a relevant field such as pharmacy, chemistry, pharmacology, nursing, or drug development.
• Knowledge of the Medicines Australia Code of Conduct
• Pharmaceutical industry experience particularly in roles related to Compliance and Pharmacovigilance.
• Demonstrate a detailed understanding of the intricate regulatory requirements for safety reporting within the Australian and New Zealand pharmaceutical markets.
• Proven track record of effectively managing external service providers, highlighting your ability to coordinate and collaborate with diverse stakeholders.

Culture
Our client fosters a culture of collaboration, excellence, and integrity. Join a stimulating and supportive work environment where your contributions drive healthcare advancements.

How to Apply
Click "apply" or contact Gemma Staddon, Specialist Manager, at 02 8877 8776 for a confidential discussion.