Pharmacovigilance Officer

1 week ago

Sydney, Australia Happy Koala LLC Full time

**About Happy Mammoth**:
**Before you dive deeper, please note the following key points**:

- This is a** fully remote c**ontractor role, available full-time.

**_ Role Purpose_**

**The** Pharmacovigilance Manager** will be responsible for overseeing and maintaining the company’s pharmacovigilance system, while also supporting the development and monitoring of a parallel system in the U.S. This role ensures compliance with regulatory requirements for safety monitoring, adverse event reporting, and risk management of therapeutic herbal supplements.**:
**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.

**Major Focus Areas**:

- 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.

**Ideal Background (High-Level)**:

- 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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