Pharmacovigilance Compliance Specialist
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Søborg
Are you an experienced pharmacovigilance professional looking for a dynamic role, where you can combine your project management skills and natural drive for improvement? Do you want to be part of an organisation where passion and engagement are met with opportunities for professional development? Then read more about our new job opening for Pharmacovigilance Compliance Specialist. Apply now for this life-changing career opportunity! The position In this position, you will play a key role in contributing towards ensuring safeguarding the patients in connection with the integration of pharmacovigilance processes and systems after newly acquired assets into Novo Nordisk. You will play a key role in setting the framework and driving the integration activities in Global Safety, which requires strong project management skills to lead and execute planned activities.
Main responsibilities include: Driving the integration of pharmacovigilance processes and systems after acquisitions and mergers of new companies or products Developing and maintaining the Global Safety framework for integration activities and the due diligence process Contributing to the process improvement initiatives, and when needed participate in audits and inspections Ensuring coherence between regulatory requirements and internal operating procedures and guidelines in collaboration with other colleagues You will be working within QPPV Office in Global Safety, located in Novo Nordisk headquarters (HQ) in Denmark. This is an opportunity to join a high-performing team of around 12 pharmacovigilance professionals with different backgrounds within life sciences working with various aspects of pharmacovigilance system compliance Qualifications We believe that diversity drives value for Novo Nordisk, therefore our company is a mix of multicultural community. Fluency in both written and spoken English is required to communicate effectively. To be successful in this role, you need the following: Academic degree in Life Sciences such as Biomedical, Pharmaceutical Sciences or similar A minimum of 8 years of experience within Pharmacovigilance, preferably with handling Safety Data Exchange Agreements and/or pharmacovigilance compliance systems and processes Experience in or working in partnership with biotech or smaller pharmaceutical companies as well as Contract Research Organisations Solid knowledge of Pharmacovigilance principles and international regulations Experience with project management involving multiple stakeholders Interest in IT systems and analytical skills As a person, you need to have a natural drive to always find ways of improvement, without compromising on quality. You are enthusiastic about working in a highly regulated compliance environment with complex projects and stakeholders. Excellent collaboration and communication skills are essential. Furthermore, we expect you to work independently and drive a variety of tasks with responsibility for delivering according to targets. About the department
Global Safety is globally responsible for the patient safety. Global Safety Compliance is in the QPPV Office. Primary responsibilities of QPPV Office are handling and maintaining Pharmacovigilance/Safety Data Exchange Agreements, Pharmacovigilance System Master File, Regulatory Surveillance and coordination of Pharmacovigilance Audits and Inspections as well as monitoring compliance & effectiveness for pharmacovigilance processes. Furthermore, we help HQ functions and affiliates across Novo Nordisk by providing pharmacovigilance advice and support regarding handling of safety in Customer Engagement Programmes and Digital Health initiatives. We use our diversity to generate novel ideas and create high-quality solutions leading to continuous improvement in pharmacovigilance processes to ensure optimal support to the Novo Nordisk Global Safety and affiliates worldwide in safeguarding the patients using Novo Nordisk products. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re 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’re all working to move the needle on patient care. Contact For further information, please contact Ea Marie Holst at +45 3448 7798. D eadline 15th January 2024. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. Please briefly explain what motivated you to apply for this role. Include your statement either in CV or Cover Letter if there is one. To ensure an efficient and fair recruitment process, please refrain from adding a photo 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.
Main responsibilities include:
Global Safety is globally responsible for the patient safety. Global Safety Compliance is in the QPPV Office. Primary responsibilities of QPPV Office are handling and maintaining Pharmacovigilance/Safety Data Exchange Agreements, Pharmacovigilance System Master File, Regulatory Surveillance and coordination of Pharmacovigilance Audits and Inspections as well as monitoring compliance & effectiveness for pharmacovigilance processes. Furthermore, we help HQ functions and affiliates across Novo Nordisk by providing pharmacovigilance advice and support regarding handling of safety in Customer Engagement Programmes and Digital Health initiatives. We use our diversity to generate novel ideas and create high-quality solutions leading to continuous improvement in pharmacovigilance processes to ensure optimal support to the Novo Nordisk Global Safety and affiliates worldwide in safeguarding the patients using Novo Nordisk products. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re 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’re all working to move the needle on patient care. Contact For further information, please contact Ea Marie Holst at +45 3448 7798. D eadline 15th January 2024. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. Please briefly explain what motivated you to apply for this role. Include your statement either in CV or Cover Letter if there is one. To ensure an efficient and fair recruitment process, please refrain from adding a photo 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 5.1.2024, 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.
- Apoteker
- Søborg
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