Safety Operations Outsourcing Specialist

 Do you have solid knowledge of drug safety/pharmacovigilance and clinical drug development, combined with project management experience? Do you have a strategic mindset and strong communication skills as well as an interest in working with suppliers within Pharmacovigilance activities?

You might be the one we are looking for to be part of driving outsourcing of safety case processing and event adjudication activities related to clinical trials to supplement our internal handled activities in our well-established Safety Operations area. We are seeking a highly motivated Safety Operations Outsourcing Specialist to oversee and support the development of an outsourcing model for Safety Operations activities related to clinical trials.

Apply today for a life-changing career!

The position

As a key member of the team responsible for setting up a new outsourcing initiative, you will develop and implement vendor management strategies and processes to ensure its success. You will manage relationships with internal stakeholders across the value chain and external partners and optimise vendor performance to meet business needs.

Your key responsibilities will include:

• Collaborate closely with internal stakeholders to define project requirements, timelines, and deliverables.
• Together with the team members across the value chain you will ensure the outsourcing model is in compliance with regulatory requirements, internal quality processes, and industry standards.
• Manage relationships with external vendors and performance monitoring against established metrics and KPIs, and develop improvement plans as needed. You will continuously evaluate and improve vendor management processes and tools to increase efficiency and effectiveness.
• Being responsible for identifying and mitigating risks associated with outsourcing Safety Operations activities and provide regular updates to Safety Operations management on vendor performance and projects status.
• Assuming responsibility, communicating information and taking action will be essential parts of your workday.
   

Qualifications

To thrive and succeed in the role, we expect you to have:

• A MSc degree in Life Science.
• Strong experience within the pharmaceutical industry with a thorough understanding of the R&D value chain.
• Experience working together with or within CROs.
• Strong experience and understanding of processes and regulatory requirements within pharmacovigilance and clinical trial regulation.
• Proven project management experience, background in leading cross functional projects would be an asset.

As a person, you possess strong interpersonal skills, coupled with a proactive, independent, and structured nature that drives you to take initiative and move things forward. You bring a strong analytic mindset, with the ability to identify critical paths and parameters essential for value creation, enabling you to design and lead assessment processes and future project plans. Additionally, you are self-driven with the capability to effectively influence and inspire others.

About the department

Safety Operations Processes is a department within Safety Operations in Global Safety and is situated in Søborg, Denmark. We are a team of dedicated and knowledgeable colleagues that support across the Safety Operations area and are responsible for warranting compliance with regulatory requirements, supporting audits and inspections, and ensuring the governance of Standard Operating Procedures (SOPs).

We also streamline training programmes, support outsourcing and integration activities in addition to driving process innovation and optimisation. Lastly, we ensure alignment across the Novo Nordisk Safety hubs in Denmark, India, Mexico, and the US.

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 Ellen Ravn Englev (Senior Director ) at +45 30793567.

Deadline

1 December 2024

Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible.

Please include a few sentences about why you are applying for this position in your resume or CV. You do not need to attach a cover letter to your application.  To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.