We are seeking a Senior Pharmacovigilance Contractor to join a very busy, high-performing affiliate safety team supporting a diverse portfolio of medicines and devices. This is a hands-on yet strategic role focused on ensuring full compliance with local and global pharmacovigilance requirements.
The Role You will be responsible for ensuring affiliate compliance with internal policies and external regulatory requirements, acting as a key local Pharmacovigilance contact.
Key responsibilities include:
- Oversight and execution of nationally required pharmacovigilance activities, including adverse event management, expedited and periodic reporting
- Serving as the local point of contact for safety matters and liaising directly with the Therapeutic Goods Administration (TGA) and/or Ministry of Health on safety issues
- Reviewing and maintaining Risk Management Plans (RMPs), local risk minimisation measures, and post-authorisation safety activities
- Influencing and partnering with cross-functional brand teams to proactively reduce product risk
- Supporting and overseeing high-volume case processing, including case entry, follow-up, reconciliation, expedited reporting, and archiving
- Ensuring the Pharmacovigilance System Master File (PSMF) and associated local documentation are accurate and inspection-ready
- Monitoring and interpreting local pharmacovigilance legislation and ensuring appropriate implementation for medicines and devices
- Maintaining third-party and business partner safety agreements
- Driving inspection and audit readiness and supporting affiliate audits and regulatory inspections
- Providing local PV training and acting as a subject matter expert within the affiliate
- Extensive pharmacovigilance experience within a pharmaceutical environment
- Strong working knowledge of Australian pharmacovigilance legislation and direct experience interacting with the Therapeutic Goods Administration
- Demonstrated experience reviewing and implementing risk management measures
- Proven ability to manage high case volumes while maintaining accuracy and compliance
- Experience maintaining PSMF documentation and supporting inspection readiness
- Strong knowledge of quality systems, SOPs, and global/local PV frameworks (including awareness of EU QPPV structures)
- A degree in Pharmacy, Nursing, Life Sciences, or equivalent experience in patient safety
- Excellent written and verbal communication skills, including professional medical terminology in English
- A proactive, organised, and influential approach with the ability to work cross-functionally without line management authority
- Join a globally recognised pharmaceutical organisation
- Take ownership of affiliate pharmacovigilance compliance in a senior-level contractor capacity
- Work within a collaborative but high-demand environment where your expertise will make an immediate impact
- Hybrid working model (3 days in office) offering flexibility and team engagement
