Safety Surveillance Process Specialist - Inspections & Compliance (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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Are you passionate about playing a pivotal role in Safety Surveillance to ensure the highest patient safety standards? Would you like to join a cross-functional department who oversee and steer some of the key processes, compliance and training across Safety Surveillance ?

If so, we invite you to apply for an exciting opportunity in Safety Surveillance Office department. This is your chance for a life-changing career!

The position
As a Safety Surveillance Process Specialist, you will take on a variety of responsibilities focusing on inspections, audits, and compliance monitoring. You will drive and collaborate closely with diverse colleagues across Safety Surveillance to optimize processes, ensuring greater simplicity and value-added work. You will be recognized as an expert in key processes and will participate in various process improvement projects aligned with our strategic objectives.

Your key responsibilities will include:

• Being responsible for the Safety Surveillance contribution to audits and inspections in Global Patient Safety, other HQ functions and affiliates
• Co-driving Regulatory Surveillance process in Safety Surveillance to ensure full compliance with applicable legislation
• Handling deviations and change requests in close collaboration with relevant colleagues in Safety Surveillance
• Taking charge of Safety Surveillance integration and acquisition activities
• Acting as Process Expert or being a back-up for key processes

You will get the opportunity to work independently and in collaboration with a team of highly skilled and committed colleagues. You will establish close partnership and interaction with other functional areas within Global Patient Safety and across Novo Nordisk. Assuming responsibility, communicating information and acting will be essential parts of your workday.

Qualifications
To succeed in the role e expect you to have:

• A Master’s degree in Life Science (e.g., Pharmacy, Medicine, Veterinary, or Biology) or in a related field
• 5-7 years of experience in drug safety/pharmacovigilance; experience in clinical development is a plus
• Demonstrated experience in facilitating inspection setups, training colleagues, and preparing the organization for audits and inspections
• Solid background in handling deviations and implementing process changes
• Experience in process management and project management is highly advantageous

As a person you are ethical and responsible, well-organized and an effective communicator. You excel under pressure and are a dedicated team player who thrives in a multicultural environment focused on continuous development. Your ability to establish strong connections and collaborate effectively with stakeholders contributes to your success in building productive relationships.

You are fluent in English both written and spoken (company language) and an experienced user of MS Office.

About the department
Safety Surveillance is a department within Global Safety and is situated in Søborg, Denmark. We also have departments in Bangalore, India and Boston, US. We are globally accountable for surveillance of all safety information for Novo Nordisk’s products that are currently marketed or under development. We additionally handle safety label updates, preparation of Risk Management Plans and aggregate reports.

The Safety Surveillance Office, a department within Safety Surveillance, comprises seven highly engaged and skilled employees.

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, Director Mona Khan mnkn@novonordisk.com

Deadline
6th of April 2025

Please note that applications are screened on an ongoing basis, so we encourage you to apply as soon as possible.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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.