Pharmacovigilance Specialist

4 days ago


Sydney, Australia Healthcare Professionals Group Full time

**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.

**Job details**:

- Location
- Sydney
- Salary
- Competitive Salary + Benefits
- Job Type
- Full Time
- Ref
- BH-41493
- Contact
- Gemma Staddon
- Contact phone
- +612 8877 8776
- Posted
- about 2 hours ago



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