Pharmacovigilance Senior Manager
5 days ago
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Category: Reg Affairs & Safety Pharmacovigilance
Location:
Ørestad, Capital Region of Denmark, DK
Are you passionate about ensuring patient safety and compliance in pharmacovigilance? Do you have a knack for strategic oversight and collaboration across international teams? We are looking for a Pharmacovigilance Senior Manager to join our team.
This role will be based in Copenhagen, Denmark or either based in Istanbul or Warsaw and will report directly to Senior Regulatory Director.
If you are ready to make a difference in patient safety, read more and apply today for a life-changing career.
The PositionAs a Pharmacovigilance Senior Manager, you will be responsible to represent a diverse Region in different global forums and be the first point of contact of Emerging Markets (EM) in Pharmacovigilance (PV) related matters for the affiliates, regional office team and Global Patient Safety organization. Also, you will be responsible to coordinate the Pharmacovigilance activities in our markets to safeguard patient safety and compliance and give the guidance needed for our teams. Moreover, you will be responsible for leading the high skilled Region EM PV Leadership Team that includes affiliate QPPVs and safety responsible persons. In addition, your responsibility will be to handle the full regional oversight of PV activities including mapping the process, complexity and responsibility; with respect to regulations and available resources to drive an optimized working model.
Main Accountabilities- Establishing and maintaining a strong awareness in Patient Safety and a robust Pharmacovigilance governance system, so that the PV roles, processes, and responsibilities are strongly anchored in the affiliates aligned with their local requirements and the international requirements.
- Ensure proactive approach is implemented for compliance: frequent review and trending of PV deviations, ICSR compliance, resource issues, etc.
- Be a strategic partner for region-initiated Customer Engagement Projects by having close collaboration with other relevant functions.
- Review, monitor, and approve Safety Data Exchange agreements with third-party service providers and collaborate with Quality Assurance counterparts to ensure qualification of external PV partners for Regional level projects.
- Plan audit/inspection preparation and ensure affiliate readiness for PV audits and inspections.
As a Pharmacovigilance Senior Manager, you need to have a University Degree in Pharmacy, Medicine, or a related medical background. Moreover, you need to have over 7 years of experience in Pharmacovigilance with solid international team experience.
To be effective in this role, you should have:
- Strong stakeholder management and communication skills.
- Ability to lead teams without direct reporting lines and drive strategy.
- Advanced English language skills.
- Solution-oriented mindset, attention to detail, and proactive approach.
- Ability to navigate diverse setups and self-motivation.
Located in Copenhagen, Denmark, our department is at the forefront of ensuring regulatory compliance and patient safety. We work diligently to safeguard patients by making sure medicines are safe to use, covering both products under development and those already on the market. Our team is dynamic and collaborative, focusing on collecting, analysing, and reporting safety data while continuously looking for new safety signals. Join us in our mission to make a difference in patient safety and regulatory affairs.
Working at Novo NordiskAt 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 to manufacturing, marketing, and sales – we're all working to move the needle on patient care.
ContactPlease click on "apply now" to submit your resume in English.
DeadlinePlease apply before the deadline 12th March 2025.
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.
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