Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
The Drug Safety & Pharmacovigilance Lead will contribute to the achievement of the Group's strategic goals, supporting safety activities for both pre- and post-authorisation assets. This role will support the Drug Safety and Pharmacovigilance Department with safety surveillance systems to monitor and evaluate safety data to mitigate potential risks. They will act as Deputy EU QPPV and ensure compliance with EU regulations. Collaboration with cross-functional teams will be essential to ensure a cohesive approach to drug safety, ultimately protecting patient safety and supporting the Group's strategic objectives.
Key Accountabilities:
- Act as Deputy EU QPPV for Telix during EU QPPV absences
- Support end-to-end pharmacovigilance activities for pre- and post-market assets: ICSR management, aggregate report writing, signal detection activities, literature reviews, regulatory intelligence reviews, database validations, audits and inspections, oversight/management of local PV network whilst ensuring regulatory compliance across all assets
- Support pre-authorisation pharmacovigilance activities of assets in new geographies, e.g. development of RMPs, xEVMPD registrations, PSMF maintenance, etc.
- Collaborate with VP, Drug Safety and Pharmacovigilance to develop procedures for Pharmacovigilance and Clinical Safety
- Support internal business units with all matters related to Drug Safety and Pharmacovigilance, e.g. Quality Assurance, Regulatory Affairs, Customer Services, Contract Management and Business Development, etc.
Education and Experience:
- Undergraduate degree, with a focus on scientific or engineering discipline
- 5+ years' experience in Pharmacovigilance in the Nuclear Medicine or Pharmaceutical environment (mandatory)
- Strong experience in EU post-market PV, incl. ICSR case handling, signal detection, aggregate report authoring, audits and inspections, ICSR submissions, compliance monitoring, working with PV vendors, etc.
- Strong experience in clinical safety, incl. SMP authoring, SAE and pregnancy report handling, SUSAR submissions to regulators and ethics board, DSUR authoring, compliance monitoring, reporting to IDMC, etc.
- Knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other global safety regulations in clinical and post market settings
Key Capabilities:
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
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