Pharmacovigilance Associate

Req ID:  7217
Date:  28 Apr 2026
Site:  VCCC (Parkville)
Location: 

MELBOURNE, VIC, AU, 3000

Company:  Peter MacCallum Cancer Centre
Unit:  Office Of Cancer Research
Division:  Cancer Research
Department:  Office Of Cancer Research
Enterprise Agreement:  Health and Allied Services, Managers and Administr
Office Of Cancer Research

At Peter Mac we aim to continuously improve cancer care, research and education across all cancers and for all people affected by cancer: changing lives, breaking new ground. Everything we do is underpinned by our core values, Excellence, Compassion and Innovation. Welcoming people from a wide variety of different backgrounds and experiences is critical to fostering innovation, cultivating compassion, attracting and retaining top talent and providing the best possible cancer care for our patients.

 

YOUR ROLE IN OUR FUTURE

 

Pharmacovigilance Associate

 

  • Ongoing, full time position (Hours negotiable)
  • Pay scale range: Grade 4 HS4 - HS29 ($83,657.60 to $110,500.00)
  • Attractive salary packaging options available

 

About the role

The Pharmacovigilance Associate manages the pharmacovigilance activities and risk management strategies relating to the collection, evaluation, documentation and regulatory reporting of clinical trial safety events that require Sponsor, Human Research Ethics Committee (HREC), regulatory authorities and contract-based reporting.

The Pharmacovigilance Associate provides advice on national and global regulatory processes Including the management of TGA approvals/notifications, deviation assessments and clinical trial registration.
Additionally, the Pharmacovigilance Associate provides expert support to the hospital’s Pharmacovigilance Committee.

 

About you

You will have excellent written and verbal communication skills with advanced administrative skills and an ability to prioritise tasks.

  • Degree in one or more of the following disciplines: Life, Biological or Health Sciences, Pharmacy
  • Relevant experience in a pharmaceutical company or Contract/Clinical Research Organisation
  • High degree of accuracy with attention to detail
  • Familiarity with Good Clinical Practice (GCP) and understanding of national and international pharmacovigilance regulations, guidelines and policies
  • Ability to solve technical and procedural problems
  • Ability to work independently, with Committees and as a member of a team
  • Appropriate computer skills (ie MS Word/ Excel/ safety reporting databases)

 

Our benefits

We offer a range of benefits which support our people both personally and professionally, including:

  • Up to $11,660 in salary packaging to increase your take home pay
  • Discounted health insurance and eye care
  • A comprehensive health and wellbeing program
  • Public transport options at our doorstep and end of trip facilities for cyclists
  • Onsite eateries and coffee shops and inviting rooftop garden spaces
  • Pathways for professional development and new career opportunities
  • Five weeks annual leave, 17.5% leave loading, purchased leave options & monthly ADOs
  • Flexible, hybrid working practices

 

Inclusion and belonging

Peter Mac celebrates, values and supports a diverse and inclusive environment which reflects our vibrant community.  We encourage applications from anyone identifying as Aboriginal and/or Torres Strait Islander.  We also welcome anyone who identifies as LGBTQIA+, linguistically, culturally and/or gender diverse, people with disability, and people of any age to apply for our roles.

 

Join us!

If you feel this role is right for you we warmly invite you to apply, and encourage your early application.  All appointments are made subject to a satisfactory police check and may include vaccination requirements.  Should you need assistance or require any adjustments or accommodations to fully participate in the application or interview process, you are welcome to reach out to the contact person listed.  We acknowledge that not all applicants will meet the full list of selection criteria outlined, and wherever possible we will consider applications where relevant experience can apply.


Applicants to this role should provide a covering letter outlining relative key skills and experience to assist us with our assessment.

For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position summary. Alternatively, please contact us using the information below for a confidential discussion.
 

Contact Person: Kylie Shackleton

Contact Details: kylie.shackleton@petermac.org 

 

Closing Date: 11:59pm Tuesday 12 May 2026.

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Position Summary

The Pharmacovigilance Associate manages the pharmacovigilance activities and risk management strategies relating to the collection, evaluation, documentation and regulatory reporting of clinical trial safety events that require Sponsor, Human Research Ethics Committee (HREC), regulatory authorities and contract-based reporting.


The Pharmacovigilance Associate provides advice on national and global regulatory processes Including the management of TGA approvals/notifications, deviation assessments and clinical trial registration.
Additionally, the Pharmacovigilance Associate provides expert support to the hospital’s Pharmacovigilance Committee.

Enterprise Agreement

Health and Allied Services, Managers and Administrative Workers

Classification or Salary Range

Grade 4: HS4

Immunisation Risk Category

Immunisation Category C

Key Relationships

Internal:

  • Office of Cancer Research
  • Clinical Research Support Team Pharmacovigilance
  • Committee
  • Clinical Trial Investigators
  • Clinical Research Staff
  • HREC Secretariat
  • Biostatistics and Clinical Trials Department (BaCT)
  • Parkville Cancer Clinical Trials Unit (PCCTU)
  • Clinical Research Managers
  • Other disciplines involved in the conduct and support of clinical trials


External:

  • External Commercial partner
  • Collaborative Research Groups
  • Regulatory authorities
  • External clinical trial sites

Skills

Essential Requirements:

  • Degree in one or more of the following disciplines: Life, Biological or Health Sciences, Pharmacy
  • Relevant experience in a pharmaceutical company or Contract/Clinical Research Organisation
  • High degree of accuracy with attention to detail
  • Familiarity with Good Clinical Practice (GCP) and understanding of national and international pharmacovigilance regulations, guidelines and policies
  • Excellent written and verbal communication skills
  • Excellent administrative skills and ability to prioritise tasks
  • Ability to solve technical and procedural problems
  • Ability to work independently, with Committees and as a member of a team
  • Appropriate computer skills (ie MS Word/ Excel/ safety reporting databases)

Key Accountabilities

Key Accountabilities Demonstrated By / Key Performance Indicators
1. Leadership and Engagement
  • Provide leadership in developing effective and efficient pharmacovigilance practices and to ensure full capture of trial safety events
  • Provide advice on national and global regulatory processes
  • Assist the Manager Clinical Research in promoting Peter Mac’s research capabilities and supportive research environment to internal and external stakeholders to foster research collaboration
  • Notify Research Management of issues
2. Pharmacovigilance
  • Provide secretariat support to the Pharmacovigilance Committee
  • Support the preparation and participation in internal and external audits including reconciliation of reporting
  • Identify any hubs of clinical research activity not fully aware or engaged in adequate safety reporting processes and extend support
  • Ensure safety database is complete, accurate and meeting safety reporting functions
  • Ensure full capture, review and reporting of safety events in studies sponsored by Peter Mac, within required timelines
  • Provide input to safety data exchange agreements
3. Communication
  • Develop and maintain key safety documents including Standard Operating Procedures and process guidelines
  • Support formulation of responses to regulatory authorities
  • Proactively identify issues and propose solutions for improvement
  • Ensure all relevant documents are maintained according to document management principles, stored in a retrievable manner and scanned to appropriate databases
  • Provide training in adverse event report
4. Professional & Personal Development
  • Support the Peter Mac Pharmacovigilance Committee processes
  • Ability to prioritise, multi-task and meet deadlines
  • Attend relevant educational/professional forums
  • Participate in team/departmental/professional society fora
  • Maintain working knowledge of ICH GCP and national and international pharmacovigilance guidelines

 

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WHY WORK FOR PETER MAC

 

Peter Mac offer a range of benefits which support our people both personally and professionally.


Our staff benefits include award winning facilities, professional development and events, a health and wellbeing program, flexible work practices and policies and financial benefits such as salary packaging.
We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQI community and people with a disability.