Senior Associate in Patient Safety
hace 5 días
About Novo Nordisk
Novo Nordisk is a prominent global healthcare organization dedicated to combating serious chronic diseases. With a century-long legacy, we are expanding our reach and commitment to improving the lives of millions worldwide.
Position Overview
We are seeking a Senior Associate in Patient Safety to become a vital part of our Clinical, Medical & Regulatory department. This role is ideal for individuals who possess meticulous attention to detail, excellent communication abilities, and a strong commitment to regulatory compliance.
Key Responsibilities
- Manage the receipt, documentation, triage, and quality evaluation of incoming safety information, including adverse events and technical complaints.
- Ensure adherence to all internal and external safety reporting requirements related to drug and device safety.
- Conduct duplicate searches, product coding, and narrative generation.
- Handle incoming and outgoing communications regarding adverse events and technical complaints, providing timely and professional responses to inquiries.
- Support the training and mentoring of new team members and assist in the coordination of workload distribution.
- Identify and recommend improvements to procedures, facilitating the implementation of effective solutions.
Qualifications
- 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.
- Preferred experience with MedDRA coding and adverse event identification.
- Knowledge of disease states relevant to Novo Nordisk, such as diabetes, obesity, and haemophilia, is advantageous.
- Fluent in both Spanish and English.
- Familiarity with FDA regulations and Sarbanes-Oxley compliance is a plus.
- Proficient in writing and executing test cases.
Department Overview
The Clinical, Medical & Regulatory department at Novo Nordisk 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 data.
Working at Novo Nordisk
At Novo Nordisk, we value the unique skills and perspectives of our diverse workforce. Our collective efforts drive us toward a greater purpose, impacting the lives of over 40 million patients daily. We are committed to fostering an inclusive culture that celebrates diversity and empowers our employees.
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