Pharmacovigilance Manager

Happy Mammoth PTD LTD; Council of the City of Sydney; Remote; AUD 90,000 - 120,000; Full time

Job summary

A health-focused e-commerce company is seeking a Pharmacovigilance Manager to oversee the company's pharmacovigilance system. This fully remote role involves ensuring compliance with TGA and FDA regulations, monitoring adverse events, and collaborating with internal teams to support safety data collection and reporting. Ideal candidates should have experience in pharmacovigilance or regulatory affairs and strong analytical skills.

Qualifications

• 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 and analytical skills.

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.
• Ensure timely and accurate submission of adverse event reports to regulators.
• Coordinate safety data collection and case processing for herbal products.
• Collaborate with internal teams for accurate capturing of safety information.

Skills

Regulatory compliance

Analytical skills

Attention to detail

Job description

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 https://happymammoth.com/.

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.

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.