Pharmacovigilance Manager

Happy Mammoth; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job summary

A growing e-commerce health company is seeking a Pharmacovigilance Manager to oversee their pharmacovigilance system. The role involves ensuring compliance with TGA and FDA regulatory requirements for safety monitoring and adverse event reporting. Candidates should have prior experience in pharmacovigilance and regulatory affairs, with strong attention to detail and analytical skills. This position is fully remote, focusing on candidate locations in Australia.

Qualifications

• Previous experience in pharmacovigilance, regulatory affairs, or related healthcare compliance role.
• Familiarity with TGA and FDA requirements for alternative/over-the-counter medicines.

Responsibilities

• Monitor, evaluate, and report on all adverse events in line with TGA and FDA regulations.
• Maintain and oversee the pharmacovigilance system for Australia and the U.S.
• Ensure timely and accurate submission of adverse event reports to regulators.
• Coordinate safety data collection, case processing, and documentation.

Skills

Pharmacovigilance experience

Regulatory compliance knowledge

Attention to detail

Analytical skills

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.