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
As a Pharmacovigilance Scientist, you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. Your primary responsibility will be to monitor, assess, and report adverse drug reactions (ADRs) and other safety-related information associated with our company's products. You will collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to collect, analyze, and interpret safety data from various sources, such as clinical trials, post-marketing surveillance, literature, and spontaneous reports.
Key Accountabilities:
Data entry of ICSRs and SAEs from Telix's authorized products and sponsored clinical trials.
Perform safety submissions of ICSRs and SUSARs within jurisdictions applicable and ensuring cross reporting is performed to Telix partners as required.
QC of safety reports where safety processes are outsourced to an external vendor.
Mailbox management of PV related concerns.
Monthly reconciliations with internal and external partners.
Literature reviews and assessments.
Provide training to internal and external business units on safety information reporting.
MHRA, TGA, FDA, EMA, Health Canada monitoring for ICSRs.
Education and Experience:
Bachelor's degree (scientific discipline) required.
2+ years' experience in Pharmacovigilance in the Nuclear Medicine or Pharmaceutical environment required.
Prior CRO experience highly desirable.
Experience in pre-and post-market Pharmacovigilance, incl. case entry and narrative writing for ICSRs and SAEs, QC-ing reports, performing submissions to regulatory authorities in accordance with local regulations.
Understanding of PV principles, regulations and guidelines including knowledge of relevant regulatory authorities such as FDA, EMA, TGA, PMDA and ICH.
Familiarity with PV requirements for safety reporting, ICSRs, SUSARs, PSURs, PADERs, DSURs and other safety related documents for regulatory submissions.
Participation in PV audits and inspections.
Ability to collaborate effectively with cross-functional teams including Medical Affairs, Clinical Operations, Regulatory Affairs, Clinical Science and Quality Assurance to ensure compliance with PV requirements.
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.
VIEW OUR RECRUITMENT PRIVACY POLICY HERE.
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