Director, Pharmacovigilance Compliance

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Søborg

Do you want to play a key role in the further development and drive of the ongoing pharmacovigilance activities? Would you like to be part of one of the most skilled and advanced pharmacovigilance (PV) functions in Denmark? Are setting direction and inspiring a team of highly engaged professionals your key competencies and passion? If you find these challenges exciting and inspiring, then you may be our new leader for the Pharmacovigilance Compliance team. Apply today for a life-changing career! The position In this role, you will play a key role in delivering the department strategy as well as execution of plans to ensure compliance with regulatory requirements through:
  • regulatory surveillance and maintenance of global oversight of pharmacovigilance and device vigilance requirements,
  • maintenance of the Pharmacovigilance System Master File and PV agreements,
  • advice and support regarding handling of safety in customer engagement programmes and digital health activities,
  • timeliness trending and metrics of individual case safety report submission,
  • coordination of PV audit and inspection-related activities.
    • Strong collaboration with other departments within Global Safety, and our stakeholders in Affiliates and headquarters is essential for the role. You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional and inclusive collaboration, and international communication will be part of your workday. You can look forward to setting direction and providing guidance to your team, taking responsibility for your department’s budget, and implementing continuous quality improvement projects. Ensuring safe products and compliance with regulatory requirements is at the heart of Novo Nordisk's business. By being part of developing the QPPV Office you can make your mark on our business. Qualifications To be successful in this job, we imagine that you have:
  • An academic degree in Life Sciences such as Biomedical, Pharmaceutical or Medical Sciences or a similar degree
  • Some years of successful experience as a people manager, who is able to motivate, develop and empower highly educated and independent professionals
  • Solid knowledge and experience in pharmacovigilance
  • You are fluent in both written and spoken English
  • Experience in working within different areas within value chain of pharmaceutical industry will be an advantage.
    • Moreover, you are enthusiastic, energetic, confident and a strong team player. Evidently, you have a good sense of urgency and cope well under pressure still maintaining a good sense of humour. You have demonstrated strategic planning skills and possess strong communication and presentation abilities. Lastly, you are able to work effectively in a highly matrix team structure and capable of influencing cross-functional working groups. About the department The position is placed in the QPPV Office, an area within Global Safety, located in Novo Nordisk headquarters (HQ) in Denmark. Global Safety is globally responsible for handling of adverse events and monitoring patient safety in Novo Nordisk. The primary responsibilities of QPPV Office are to provide support to Novo Nordisk’s Qualified Person Responsible for Pharmacovigilance (QPPV) by handling and maintaining PV Agreements, Pharmacovigilance System Master File (PSMF), regulatory surveillance and coordination of PV Audits and Inspections as well as monitoring compliance & effectiveness for pharmacovigilance processes. Furthermore, we help other HQ functions and affiliates across Novo Nordisk by providing pharmacovigilance advice and support regarding handling of safety in customer/ patient 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 Wasim Anwar at +45 3079 6766. Deadline 20 February 2023. Please, apply in English. Applications will be evaluated continuously when received and candidates may be called for an interview before the 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 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 24.1.2023, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Forretningsudvikler
    • Søborg
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