Renewals Manager
Lumivero
Pharmacovigilance Manager
Happy Koala
contract
Posted on:
Location Type: Remote
Location: Remote • 🇦🇺 Australia
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Oversee and maintain the company’s pharmacovigilance system for Australia and support development/monitoring of a parallel system in the U.S.
- Monitor, evaluate, and report on all adverse events in line with TGA and FDA regulations
- 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
Requirements
- At least 3 years of experience in pharmacovigilance or regulatory affairs for dietary supplements, nutraceuticals, or consumer health products
- Previous experience in pharmacovigilance, regulatory affairs, or related healthcare compliance role
- Familiarity with TGA and FDA requirements for alternative/over-the-counter medicines
- Experience preparing or reviewing adverse event reports (e.g. ICSRs) for supplement or consumer health products
- Experience with adverse event reporting, case processing, and safety surveillance
- Strong attention to detail and analytical skills
- Ability to manage compliance processes and contribute to audits/inspections
- Must be currently based in Australia
Benefits
- Fully remote work
- Contractor role (full-time availability)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilanceadverse event reportingcase processingsafety surveillanceregulatory complianceSOP developmentrisk assessmentdata collectiondocumentationhealthcare compliance
Soft skills
attention to detailanalytical skillscollaborationcommunicationorganizational skills