Protecting Patient Safety and Well-being
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* The successful candidate will have the opportunity to lead process development and enhancement relating to Clinical Safety processes.
* They will facilitate the review of Adverse Events and Device Deficiencies by appointed Clinical Safety Monitors and coordinate individual case processing and reporting to regulatory authorities and Investigators.
* This role offers a unique opportunity to make a significant impact on the development of clinical safety processes within the organization.
Key Responsibilities:
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* Escalate potential safety risks through the Clinical Review Board to ensure appropriate quality control procedures are considered and applied.
* Proactively communicate when there may be periods requiring back-up support or assistance to achieve the accountabilities of the role.
* Continually seek to raise the awareness and understanding of clinical investigation safety management requirements through day-to-day dealings with internal and external stakeholders.
* Demonstrate due diligence commitment to workplace health and safety through active involvement and implementation of WHS and Injury management procedures.
* Contribution to clinical investigation documentation through specialist input to safety-related items, and quality control checks.
About the Role
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To add value in this position, you'll be able to demonstrate the following skills and experience:
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* Minimum:
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o A Bachelor of Biomedical or Health Sciences, Nursing, Pharmacy, Pharmacology, or related discipline is required.
o Experience working alongside or in clinical data management and/or safety vigilance is necessary.
o Ability to work independently and part of a cross-functional team.
o Excellent interpersonal, written, and verbal communication skills with ability to communicate with internal stakeholders and external customers.
o Strong attention to detail with ability to manage priorities ensuring quality and timeliness of work.
o Proficiency in MS Office.
* Ideal:
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o Working knowledge of GCP (good clinical practices), medical terminology, clinical research conduct and applicable legislation and standards is desirable.
o Experience in clinical scientific or medical writing is preferred.
o Experience in the development of process/procedures is advantageous.
We Offer
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Cochlear is committed to providing opportunities for continuous learning and professional development. We offer a range of programs and benefits to support your career and personal life.
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