Patient Safety (Pharmacovigilance) Partner - 15 Months Max Term Contract
On-siteSydney, New South Wales, Australia
Job Summary
Develops strategy, informs and trains internal and external stakeholders on Roche products' safety profile and PV requirements, and leads activities to ensure inspection readiness. Oversees Individual Case Safety Report (ICSR) processing and management from all relevant sources, including Roche-managed studies, local media, and regulatory reports. Manages PV Agreements and Safety Data Exchange Agreements with external third parties while ensuring all safety information is collected and reported appropriately. Provides safety advice to internal and external parties to ensure advanced product knowledge and acts as a backup LSR or TGA Qualified Person for PV. This role requires a degree in pharmacy, life sciences, or health disciplines with demonstrated PV experience and knowledge of GVP, ICH, and TGA regulations. Full eligibility to live and work in Australia is required.
Required Qualifications
- Degree in pharmacy, other health disciplines, or life sciences
- Demonstrated experience in Pharmacovigilance (PV)
- Full eligibility to live and work in Australia
Desired Qualifications
- Demonstrated experience in Pharmacovigilance (PV) or relevant experience in a GCP area preferred
- A thorough knowledge of GVP, ICH, GCP, TGA regulations, Medicines Australia Code of Conduct and other relevant regulations, standards and guidelines
- Medical terminology - verbal and written
- An existing proficiency with PV systems and tools (e.g. ARISg) is preferred
- The ability to communicate in a concise and clear manner
- The ability to build strong collaborative relationships with key stakeholders
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