Pharmacovigilance Specialist

Benefits

• Lead PV/MDV compliance, contributing to product safety and regulatory excellence.

• Dynamic work environment with a focus on professional development and work-life balance.

• Competitive salary package + company benefits

About the Company
My client is a global pharmaceutical company specializing in innovative medical products. They have a strong presence in Australia and New Zealand, known for their commitment to quality and cutting-edge research.

About the Opportunity
In this role, you will manage Pharmacovigilance activities for Australia and New Zealand, ensuring compliance with regulations and contributing to global projects. Reporting to a senior manager locally you'll play a crucial role in maintaining product safety and regulatory compliance, impacting the business's success in the market.

Duties

• Manage PV documentation and ensure compliance.

• Participate in audits and implement corrective actions.

• Develop and deliver PV training materials.

• Manage ADR case reporting and compliance.

• Act as local responsible person for PV/medical device vigilance compliance.

• Collect, assess, and report PV/MDV cases.

• Perform local medical assessments and report to authorities.

• Interact with stakeholders on safety-related matters.

• Manage and update QMS documentation.

• Collaborate on regulatory submissions and audits.

• Provide regulatory intelligence and contribute to SOPs.

Skills and Experience

• Tertiary degree in Pharmacy, Biomedical Science, Nursing or related healthcare degree

• 2-3 years of experience within pharmacovigilance

• Good understanding of pharmacovigilance regulations and guidelines

• A fast and willing learner with a strong attention to detail

• Adaptable, proactive, strong communication & collaboration skills

Culture
Our culture is collaborative, innovative, and focused on making a positive impact in the healthcare industry.

How to Apply
Click 'Apply' or contact Gemma Staddon, Specialist Manager on 02 8877 8776 for a confidential discussion.