Clinical Safety Manager

8 months ago

Sydney, Australia Cochlear Ltd Full time

Cochlear is the global market leader in implant hearing solutions. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.

The Clinical Safety Manager will work collaboratively with Data Management, Clinical Project Managers and Clinical SMEs such as Technical Field staff, Research Audiologists, Research & Development Engineers, and Quality Post Market Surveillance. 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.

The Opportunity

Cochlear has a permanent ongoing opportunity for a Clinical Safety Manager based in our Sydney, Macquarie office. In this role, the successful Clinical Safety Manager is primarily responsible for coordinating processes for safety monitoring and reporting for clinical studies and marketed products.

Responsibilities include:

- 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 Cochlear’s WHS and Injury management procedures.
- Contribution to clinical investigation documentation through specialist input to safety-related items, and quality control checks.

What makes this opportunity unique?

The Clinical Safety Manager will raise the profile of clinical safety management with internal stakeholders and lead process development and enhancement relating to Clinical Safety processes. This may include growth of a team directly reporting to the Clinical Safety Manager.

About You. As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:
Essential

Minimum:

- Bachelor of Biomedical or Health Sciences, Nursing, Pharmacy, Pharmacology, or related discipline.
- Experience working alongside or in clinical data management and/or safety vigilance.
- Has experience in and is comfortable navigating complexity and ambiguity in business processes and structure
- Experience in MedDRA coding and handling of safety data.
- Ability to work independently and part of a cross functional team.
- Excellent interpersonal, written, and verbal communication skills with ability to communicate with internal stakeholders and external customers.
- Strong attention to detail with ability to manage priorities ensuring quality and timeliness of work.
- Proficiency in MS Office

Ideal:

- Working knowledge of GCP (good clinical practices), medical terminology, clinical research conduct and applicable legislation and standards.
- Experience in clinical scientific or medical writing.
- Experience in the development of process/procedures.

Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.

CochlearCareers

How we recognise your contribution

We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs

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