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Quality & pharmacovigilance lead

Williamstown
AgeMate
Quality
Posted: 5 April
Offer description

ATTN: Quality & Pharmacovigilance Professionals

AgeMate is an Australian founded company in the longevity space, marketing a fast growing, subscription based supplement product across multiple global markets. We are seeking a full time Quality & Pharmacovigilance Lead, Melbourne based, to join our team.

This role offers hybrid work flexibility of 3 days in the office and 2 days from home.

We are a growing team of almost 20, headquartered in Cremorne, Melbourne.

THE ROLE

As a Quality & Pharmacovigilance Lead at AgeMate, you will play a critical role in ensuring the safety, quality, and regulatory compliance of our products supplied in Australia.

You will own and operate the company's pharmacovigilance and post market surveillance processes, ensuring adverse events, product complaints, and safety signals are appropriately monitored, investigated, and reported in line with Therapeutic Goods Administration (TGA) requirements.

You will also support the company's quality oversight framework, working closely with Supply Chain, Product, Customer Service, and contract manufacturers to ensure our products consistently meet high quality standards.

This is a hands on role with full ownership of pharmacovigilance and post market compliance, and is suited to someone who has previously operated in a similar capacity within complementary medicines.

ABOUT YOU

You care deeply about product quality and consumer safety and have experience ensuring both are maintained within a regulated environment.

You have worked with TGA listed complementary medicines and are comfortable operating independently across pharmacovigilance, complaints, and post market compliance.

You are structured and detail oriented, with a strong ability to investigate issues, manage documentation, and ensure regulatory requirements are consistently met.

You are pragmatic and solutions focused, able to work cross functionally to resolve issues and improve systems without over engineering processes.

CORE RESPONSIBILITIES

Pharmacovigilance and Safety Monitoring

* Maintain the company's Adverse Event Reporting System and Adverse Event Register
* Assess and document adverse events and support reporting of serious adverse events to the TGA within required timeframes
* Monitor adverse event trends and identify potential safety signals

Product Complaints and Post Market Surveillance

* Maintain the Product Complaint Register
* Investigate product complaints and determine whether issues represent safety concerns or quality defects
* Monitor complaint and safety trends and elevate issues where required

Product Quality Oversight

* Manage internal product quality review processes
* Coordinate blind tasting panels and sensory evaluations where applicable
* Maintain the company's retained sample program for finished product batches
* Coordinate independent third‐party laboratory testing to verify product quality and label claims

Manufacturing Quality Oversight

* Support quality oversight of contract manufacturers and suppliers
* Review Certificates of Analysis (COAs) where required
* Support investigation of manufacturing issues affecting product quality

Regulatory Compliance

* Support compliance with TGA complementary medicines regulatory requirements
* Support regulatory review of product labels and ingredient compliance
* Support the company in meeting its obligations as Sponsor of therapeutic goods in Australia

REQUIRED BACKGROUND AND EXPERIENCE

This role requires hands on experience with TGA pharmacovigilance and post market requirements for complementary medicines.

* Proven experience working with TGA listed complementary medicines
* Direct experience managing pharmacovigilance and post market surveillance for products supplied in Australia
* Experience handling adverse event reporting and TGA safety reporting requirements
* Experience investigating product complaints, safety issues, and quality deviations
* Experience working with complementary medicine contract manufacturers
* Strong understanding of TGA sponsor obligations for listed medicines

SKILLS

* Strong attention to detail and documentation discipline
* Structured approach to investigations and root cause analysis
* Ability to manage safety and quality data in a clear and organised manner
* Strong communication skills when working with cross functional teams
* Ability to operate effectively in a growing, fast moving environment

ELIGIBILITY

Applicants must have full working rights in Australia.

Applicants must be based in Victoria.

HIRING PROCESS

* Application Review
* 45 Minute Video Interview
* Case Study
* Personality Psychometric Assessment
* Formal Offer and Contract Negotiations

Total expected time to hire is 3 to 4 weeks.

BENEFITS

* Hybrid Work Flexibility: 3 days in the office, 2 days from home
* Great Office Environment: No suit required
* Convenient Location: 5 minute walk from Richmond Station
* Office Amenities: End of trip facilities including showers and towels, sauna, rooftop basketball court, and golf simulator

TO APPLY

Please submit your CV in PDF format.

ABOUT US

AgeMate is an Australian founded brand dedicated to enhancing longevity through innovative nutritional products. Since 2022, we have supported customers across Australia, New Zealand, the United Kingdom, and the United States, helping over 150,000 people with thousands of positive reviews.

Join a passionate, down to earth team and play a key role in building scalable product quality and safety capability as the business grows.

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