Patient Safety Senior Associate
hace 4 días
At Novo Nordisk we don’t wait for change, we drive the change. We’re committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core.
We are looking for a Senior Patient Safety Associate to join our Clinical, Medical & Regulatory department at Novo Nordisk. If you are detail-oriented, have strong communication skills, and committed to compliance, then read on and apply today for a life-changing career.
Join Novo Nordisk for a life-changing career establishing and developing a world-class Global Business Service Centre in Mexico City.
The position
As a Patient Safety Senior Associate at Novo Nordisk, you will be responsible for:
Shared responsibility in electronic submission program for NNI Patient Safety and ensure compliance with United States (US) Federal regulations and company SOPs regarding AE reporting through administration of the system as well as paper submissions to the FDA.
Share responsibility in generating expedited and periodic submissions and retrieves safety data for pharmacovigilance queries.
Support technical operations of safety systems and technology improvements.
Participate in all submission related tasks as needed.
Qualifications
Bachelor's degree in a science or healthcare discipline.
A minimum of 4 - 6 years previous pharmaceutical industry experience required in Safety.
Knowledge of Pharmacovigilance principles and ICSR Expedited submissions.
Knowledge of ICH and FDA safety as well as cGMP regulations.
Knowledge of Argus & MedDRA coding; knowledge of programming in Oracle, Oracle Apex, InfoPath programming, Excel Macros programming and SQL server is plus.
You have Advanced or Fluent Level of Spanish and English.
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 100-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 64,000 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.
Contact
To complete your application, please submit your CV by clicking "Apply now" and following the instructions. For more details, follow our LinkedIn page: Novo Nordisk: About | LinkedIn
Deadline
Apply before December 1st, 2024
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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