Pharmacovigilance Safety System Specialist
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Søborg
Ready to take your expertise in global safety databases and pharmacovigilance to the next level? Are you committed to safeguarding patients and minimizing risks associated with Novo Nordisk products? Join us as a Safety System Specialist in this compelling temporary position. Leverage your experience to drive impactful safety measures and contribute to patient well-being. Don't miss out on this chance to be a part of our mission and elevate your career while making a difference in pharmacovigilance. Apply today for a life-changing career! The position
Your responsibility will be to work alongside your colleagues to support the ongoing maintenance, development, and continuous improvements of the global safety database to ensure the daily case processing and submission of Individual Case Safety Reports (ICSRs) to ensure regulatory compliance. In addition, we are in the very exciting process of changing our global safety database which you will also be a part of on ad hoc basis depending on your specific qualification and what is needed in the ongoing NextGen Safety project.
Key responsibilities include: Planning and prioritizing daily activities to ensure targets are met according to quality, timelines, and costs. Reviewing guidelines and regulations to evaluate their influence on departmental processes and systems, while also actively participating in cross-organizational projects and relevant working groups to ensure ongoing compliance with both internal and external guidelines and regulations within the area. Independently making valuable recommendation regarding key deliverables, which may impact critical safety deliverables. These recommendations are to be presented for endorsement by management. Evaluating and transforming business requirements into configuration changes. Configuring the safety database, including code lists, clinical trials, etc. Supporting the implementation of new processes and/or requirements with an impact across Novo Nordisk, based on new regulatory requirements or strategic decisions, and providing expert advice on complex process issues. Working with global IT and stakeholders to implement safety database changes and ensure compliance with internal and external guidelines and regulations. Qualifications
As a Safety System Specialist, you will have the opportunity to work alongside a team of dedicated and skilled colleagues in a flexible and dynamic environment. Your expertise and contributions will be highly valued as you play a critical role in impacting our processes and ensuring the safety of our products. As an ideal candidate, you have: Relevant university degree for example in biomedicine or computer science with at least 5 years of experience within drug safety/pharmacovigilance area. Solid understanding of regulatory requirements. Experience working with safety databases such as Argus, ArisG or similar from a configuration perspective. In addition, you are experienced with Connecting regulatory requirements, business processes and functionality of IT systems. Implementation of back-end changes in collaboration with IT and other relevant stakeholders. IT system risk assessment, testing, validation, implementation, and maintenance of IT systems. Working in large cross-organisational IT projects as area specialist.
As a person, you possess qualities such as ethics, pro-activity, analytical and organizational skills, in addition to excellent communication abilities. You can work under pressure when needed. You are a strong collaborator and who thrives in a multicultural environment in continuous development.
About the department
The Safety Operations PV System Support team is a department within Global Safety situated in Søborg, Denmark. The team consists of 13 highly engaged team members located in Denmark and in India. The team has the global responsibility of the support, maintenance, development, and continuous improvement of the global safety database. In summary, this is an excellent opportunity for a highly skilled and experienced Safety System Specialist to work alongside a team of skilled and dedicated colleagues. This role offers excellent development opportunities in a flexible environment where you will have a good opportunity to impact the processes.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.
Contact
For further information please contact Vibeke Gundstrup Meirum at +45 3079 3208 Deadline
17 September 2023.
We will be screening and interviewing applications on an ongoing basis, so please apply at the earliest. Application and CV should be written in English. You do not need to attach a cover letter to your application, but do remember to include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV.
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.
Your responsibility will be to work alongside your colleagues to support the ongoing maintenance, development, and continuous improvements of the global safety database to ensure the daily case processing and submission of Individual Case Safety Reports (ICSRs) to ensure regulatory compliance. In addition, we are in the very exciting process of changing our global safety database which you will also be a part of on ad hoc basis depending on your specific qualification and what is needed in the ongoing NextGen Safety project.
Key responsibilities include:
As a Safety System Specialist, you will have the opportunity to work alongside a team of dedicated and skilled colleagues in a flexible and dynamic environment. Your expertise and contributions will be highly valued as you play a critical role in impacting our processes and ensuring the safety of our products. As an ideal candidate, you have:
As a person, you possess qualities such as ethics, pro-activity, analytical and organizational skills, in addition to excellent communication abilities. You can work under pressure when needed. You are a strong collaborator and who thrives in a multicultural environment in continuous development.
About the department
The Safety Operations PV System Support team is a department within Global Safety situated in Søborg, Denmark. The team consists of 13 highly engaged team members located in Denmark and in India. The team has the global responsibility of the support, maintenance, development, and continuous improvement of the global safety database. In summary, this is an excellent opportunity for a highly skilled and experienced Safety System Specialist to work alongside a team of skilled and dedicated colleagues. This role offers excellent development opportunities in a flexible environment where you will have a good opportunity to impact the processes.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.
Contact
For further information please contact Vibeke Gundstrup Meirum at +45 3079 3208 Deadline
17 September 2023.
We will be screening and interviewing applications on an ongoing basis, so please apply at the earliest. Application and CV should be written in English. You do not need to attach a cover letter to your application, but do remember to include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV.
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.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 17.8.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forretningsudvikler
- Søborg
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