Patient Safety Specialist Submission - Gbs México [QN058]

Patient Safety Specialist Submission - Gbs México [QN058]

Patient Safety Specialist Submission - GBS México

**Category**:Reg Affairs & Safety Pharmacovigilance

**Location**:Ciudad de México, Ciudad de México, MX
- At Novo Nordisk we don't wait for change, we drive the change.
We're committed to promote and be an equal opportunity workplace andact as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at theircore.
Join Novo Nordisk for a life-changing career establishing and developing a world-class Global Business Service Centre in Mexico City.
- This is a hybrid position._

**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) Federalregulations 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 Macrosprogramming 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 workclosely 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.
Buildingon our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world andimpacting more than 40 million patient lives daily.
All of this has made us one of the 20 most valuable companies in the world by marketcap.
Our success relies on the joint potential and collaboration of our more than 64,000 employees around the world.




We recognize theimportance 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 gofurther.
Together, we're life changing.
**Contact**

**Deadline**
- 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 thebest company for the world and we know that this is only possible with talented employees with diverse perspectives,



backgrounds andcultures.
We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serveand communities we operate in.
Together, we're life changing.

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.com.mx/empleo/142687838/patient-safety-specialist-submission-gbs-mexico-qn058-xico/?utm_source=html