The position As a Patient Safety Associate at Novo Nordisk, you will be responsible for: Collecting and documenting safety information, including adverse events and technical complaints, related to our US marketed products Ensuring compliance with internal and external drug and device safety reporting regulations Performing triage and data entry of adverse events into applicable databases Handling inbound and outbound calls for adverse events and technical complaints; providing professional and timely responses to product information questions and inquiries Qualifications Bachelor's degree in a science or healthcare discipline, or relevant experience in a clinical role.
1-4 year of patient safety experience, preferably with customer service experience.
Strong knowledge of medical and pharmacovigilance terminology.
Experience with MedDRA coding and adverse event identification is preferred.
Prefferably knowledge of disease states supported by Novo Nordisk, such as diabetes, obesity, hemophilia, and growth hormone disorders, is a plus.
Advanced (Spanish-English) Familiarity with FDA regulations, computer validation, and Sarbox regulatory requirements.
Proficiency in test case writing and execution.
About the department The Clinical, Medical & Regulatory department at Novo Nordisk is dedicated to ensuring the safety and efficacy of our products.
We work closely with healthcare professionals, patients, and regulatory authorities to collect and analyze safety information.
Located at our headquarters, this department is fast-paced and dynamic, with a focus on compliance and patient well-being.
Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a -year legacy of driving change to defeat serious chronic diseases.
Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily.
All of this has made us one of the 20 most valuable companies in the world by market cap.
Our success relies on the joint potential and collaboration of our more than 63, employees around the world.
We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.
Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort.
Join us!
Together, we go further.
Together, we're life changing.
