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Senior Associate in Patient Safety
hace 2 meses
About Novo Nordisk
Novo Nordisk is a global leader in healthcare, dedicated to combating serious chronic diseases. With a rich history spanning over a century, we are expanding our impact, reaching millions globally and improving the lives of over 40 million patients daily. Our success is driven by the collaboration and potential of our 64,000 employees worldwide, who bring unique skills and perspectives to our mission.
Position Overview
We are seeking a Senior Associate in Patient Safety to enhance our Clinical, Medical & Regulatory department. This role is ideal for individuals who are meticulous, possess excellent communication abilities, and are dedicated to regulatory compliance.
Key Responsibilities
- Manage the receipt, documentation, and quality evaluation of incoming safety data, including adverse events and technical inquiries.
- Ensure adherence to both internal and external safety reporting standards related to drug and device safety.
- Conduct duplicate searches, product coding, and narrative generation.
- Handle communications regarding adverse events and technical complaints, providing timely and professional responses.
- Support the training and mentoring of new team members and assist in the distribution of workloads.
- Identify and recommend enhancements to existing procedures, collaborating with management to implement effective solutions.
Qualifications
- A Bachelor’s degree in a scientific or healthcare-related field.
- A minimum of 3 years of experience in patient safety, ideally with a background in customer service.
- Strong understanding of medical and pharmacovigilance terminology.
- Experience with MedDRA coding and adverse event identification is preferred.
- Knowledge of disease states relevant to Novo Nordisk, such as diabetes and obesity, is advantageous.
- Fluency in both Spanish and English is required.
- Familiarity with FDA regulations and compliance requirements is beneficial.
- Proficiency in writing and executing test cases is essential.
Department Overview
The Clinical, Medical & Regulatory department is committed to ensuring the safety and efficacy of our products. We collaborate closely with healthcare professionals, patients, and regulatory bodies to gather and analyze safety information.
Working at Novo Nordisk
At Novo Nordisk, we strive to be the best company for the world, fostering an inclusive culture that values diversity among our employees, the patients we serve, and the communities we engage with. Together, we are making a life-changing impact.
