The position As a Patient Safety Senior Associate at Novo Nordisk, you will be responsible for receipt, documentation, triage and quality assessment of inbound safety information, including adverse events and technical complaints.
Also responsible for ensuring compliance with all internal and external drug and device safety reporting requirements regarding the collection and maintenance of safety information.
Along with that you will: Duplicate searches, Product Coding and Narrative Generation.
Handling inbound and outbound calls and correspondence for adverse events and technical complaints, providing professional and timely responses to product information questions and inquiries.
Assist with training and mentoring of new joiners and assist with workload distribution and coordination.
Identify opportunities of development of the procedures and make recommendations to management and support implementation of solutions.
Qualifications Bachelor's degree in a science or healthcare discipline.
3+ years 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.
It will be considered as an asset if you have knowledge and experience with disease states supported by Novo Nordisk, such as diabetes, obesity, haemophilia, and growth hormone disorders.
You have Advanced or Fluent Level of Spanish and English.
Familiarity with FDA regulations, computer validation, and Sarbox regulatory requirements.
Proficiency in test case writing and execution is a must.
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 analyse safety information.
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 64, 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.
