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Specialist Safety Operations in Pharmacovigilance

Category:  Clinical Development and Medical
Location: 

Bangalore, Karnataka, IN

   

We are looking for a Senior Safety Operations Specialist in Global Safety (GS) unit based out of Global Business Service (GBS), Bangalore, India. You can look forward to an exciting job driving different projects and engaging with multiple stakeholders at the global level.

 

The position

As a Senior Safety Operations Specialist you handle adverse events and other safety information , ensuring fulfilment of global regulatory requirements to the collection, evaluation and reporting of safety information on development & marketed medicinal products & devices. Further, establishing new or improved methods of working within field of expertise by ensuring and encouraging share better practice and consistency of safety deliverables. Furthermore, act as a competent partner to line of business by providing qualified support in relation to requirements within quality, processes, products, organisation, and cooperate business objectives.

 

You will lead projects across functional areas. Define project scope, goals to be reached, expected deliverables, stakeholder mapping, estimated cost and timeline for projects and secures project approval. Further engages with vendors, challenges content and proposed costs and secures involvement of corporate souring as required.

 

You act as a deviation and change request owner. Prepare deviation reports and change reports as appropriate. Together with facilitating the root cause investigations, assess impact to existing safety processes, recommend mitigating actions and drive decision making on corrective/preventive actions.

 

You will be responsible for reviewing safety data presented in relation to audits and inspections, present global safety processes within C2.01 in global audits and inspections.

 

In collaboration with affiliates you will support implementation of new processes and/or requirements with impact across NovoNordisk based on increased regulatory requirements.

 

Qualifications

You need to have the below knowledge and skills.

  • Graduation and/or post-graduation in life sciences
  • Minimum of 7-9 years of relevant working experience within PV
  • Extensive knowledge of pharmacovigilance principles and businesses processes required for the establishment of efficient handling of safety information
  • Experience in managing a field of expertise that requires highly specialized knowledge of strategic importance to the area
  • Experience in providing training and support in a professional context
  • In depth Novo Nordisk organisational and/or pharmaceutical company understanding
  • Extensive experience in studying scientific  regulations/guidelines
  • Extensive knowledge and understanding of GxP requirements
  • Experience working with business process improvements
  • Experience with working in international and diverse professional groups
  • Fluency in English, both written and spoken

 

About the department

Global Business Service (GS-GBS) was set up in 2010 as one of the hub for safety case processing. At GS-GBS, we handle case processing from different sources including spontaneous, literature, solicited and clinical trials. Apart from complete case processing and medical review, GS-GBS is also engaged in safety report submission, training, LearnIt administration, quality control of individual case safety reports (ICSR), ARGUS configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.

 

Working at Novo Nordisk

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. We create value by putting patients first. Working here is not just a way to make a living, but a way to make a difference.

 

Contact

For further information please contact Vaibhav at vbke@novonordisk.com

 

Deadline

30 September 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.