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Lead Auditor, Specialist in Pharmacovigilance

Category:  Legal, Compliance and Audit
Location: 

Bangalore, Karnataka, IN

   

Are you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status-quo in a friendly and open-minded way? If so, there is a unique job opportunity waiting for you as our new Pharmacovigilance (PV) auditor. At Novo Nordisk, we will challenge you to do the best work of your life.

 

About the department

Novo Nordisk Quality GBS was established in May 2015. We are responsible for supporting and development of overall quality services, such as training coordination, content control, digital solutions, quality and compliance management and records management for various units within Novo Nordisk.

Here, you will be a part of an ambitious, dynamic and global team consisting of over 100+ employees who ensure high quality as well as fit-for-purpose processes for the entire value chain from research to market. We make quality easy, simple and understandable.

 

About the position

Quality Audits GBS is a group of highly experienced professionals in the domains of GCP, PV and IT and comprises of two groups: Auditors and Business Support Function. Auditors conduct audits to provide assurance of Patient Safety, Product Quality and Compliance to the organisation by following up on minor, major and critical findings with review and approval of action plans.

 

As a Lead Auditor you will be responsible for performing audits worldwide. Further, plan and conduct the assigned audits according to the audit plan and establish a unit audit plan. You will be required to document results from audits and include descriptions of observations, finding and overall conclusion.

 

You will be required to identify compliance trends & signals and communicate potential trends & signals to the audit owner. Being alert to early compliance trends & signals and act on it to increase the business value.

 

This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management, communication skills and digital savviness. Requires you to operate successfully across cultural differences.

 

Qualifications

Below are the required skills.

  • Bachelor’s or Master’s in the science/pharmacy/clinical trials
  • Minimum 10-12 years of relevant work experience
  • Excellent understanding of the business, value chain and pharmaceutical
  • Proficient with PC-tools and MS Office
  • Knowledge of the pharmaceutical industry with focus on Pharmacovigilance is a must
  • Thorough knowledge of/experience with Quality and Quality Management systems
  • Thorough understanding of relevant regulatory requirements
  • Understands the Novo Nordisk business in a wider and global context
  • Master stakeholder management
  • Master change management 
  • Strong analytical skills to facilitate and advise on complex and multidisciplinary areas.
  • Excellent communication skills – written and verbal

 

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries.

 

We 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 changing lives.

 

Contact

If you have questions about the position, you are welcome to reach out to Vaibhav Keshri at vbke@novonordisk.com

 

Deadline

30 November 2021

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.