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Job details

Location
Sydney
Salary
Competitive Salary + Benefits
Job Type
Full Time
Ref
BH-41493
Contact
Gemma Staddon
Contact email
Email Gemma
Contact phone
+612 8877 8776
Posted
23 days ago

Job details

Location
Sydney
Salary
Competitive Salary + Benefits
Job Type
Full Time
Ref
BH-41493
Contact
Gemma Staddon
Contact email
Email Gemma
Contact phone
+612 8877 8776
Posted
23 days ago
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.

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