Pharmacovigilance Officer
3 days ago
About Happy Mammoth:
Happy Mammoth is a high-growth e-commerce company dedicated to empowering women's health through natural, science-backed supplements focused on gut, digestive, and hormonal wellness. As a performance-driven company, we are passionate about making a meaningful, lasting impact on our customers' lives. You can learn more about us at
Before you dive deeper, please note the following key points:
- This is a fully remote contractor role, available full-time.
- This position is open to candidates currently based in Australia.
Key Responsibilities
- Monitor, evaluate, and report on all adverse events in line with TGA and FDA regulations.
- Maintain and oversee the pharmacovigilance system and related processes for Australia and the U.S. regions.
- Ensure timely and accurate submission of adverse event reports to regulators.
- Coordinate safety data collection, case processing, and documentation for herbal and therapeutic products.
- Collaborate with internal teams (quality, regulatory affairs, customer support) to ensure accurate capture of safety information.
- Develop and implement pharmacovigilance SOPs and best practices.
- Contribute to regulatory inspections, audits, and compliance checks.
- Support ongoing risk assessment and safety surveillance activities.
- Regulatory Compliance: Maintaining compliance with TGA and FDA pharmacovigilance requirements.
- Adverse Event Reporting: Timely monitoring, reporting, and follow-up on product-related adverse events.
- System Oversight: Building and maintaining robust pharmacovigilance systems in Australia and the U.S.
- Cross-Functional Collaboration: Working closely with internal teams to ensure seamless reporting and data integrity.
- Continuous Improvement: Supporting process development, training, and system upgrades to meet evolving requirements.
- Previous experience in pharmacovigilance, regulatory affairs, or related healthcare compliance role.
- Familiarity with TGA and FDA requirements for alternative/over-the-counter medicines.
- Strong attention to detail, analytical skills, and ability to manage compliance processes.
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