IT System Manager for Pharmacovigilance Team in Global IT
Are you passionate making good applications even better? Do you have experience within application configuration and business processes?
If so, now is your chance to join Ascendis Pharma as our new IT System Manager for the Pharmacovigilance (PV) Product Team in Global IT.
Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.
We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.
We are seeking a passionate IT Application Manager to join our growing team. As a key member of the product team in Global IT, you will play a crucial role in ensuring the deployment, validation, and documentation of configuration changes.
This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.
You will be joining the Product Team in Global IT that supports our Pharmacovigilance business function.
Global IT is on a journey to implement agile methodology and a product-mindset in the ways we work, and we need you and the rest of Global IT to help us find our way moving forward. Further, we are a cloud-first, zero legacy system environment.
You will report directly to Lene Larsen, People Leader in Global IT in Denmark and a functional reference to Ivanna Rosendal, Business Partner in Global IT, currently located in US.
Your key responsibilities will be:
- Responsible for maintaining and improving applications, including GxP critical IT systems.
- Ensure understanding of business processes and requirements and translating these to technical requirements for the vendors to implement.
- Work with the other members on the team to develop application roadmaps aligned with business and IT goals.
- Coordinate with cross-functional stakeholders such as IT infrastructure, QA IT, Software vendors, support partners to ensure efficient delivery of applications changes.
- Responsible for system administration and technical support, for instance ensure access request and incidents are resolved.
- Develop training material and ensure well-trained user base.
- Ensure periodic reviews are conducted to maintain compliance to GxP regulation.
- Develop application documentation as per SDLC methodology and operational documentation such as SOPs, work instructions and user manuals.
Qualifications and Skills:
You hold a relevant academic degree – preferably a master’s degree, but not necessarily – and 5+ years of experience as a System Manager, Application Manager, Solution Architect, Validation Manager or a similar role from a biotech, pharmaceutical company or consultancy catering to the pharmaceutical industry.
Furthermore, you have:
- Experience with maintaining applications from the field of PV
- Deep business process knowledge in either Quality, Regulatory or Pharmacovigilance.
- Strong configuration skills
- Extensive experience with GxP validation such as 21 CFR Part 11 and GAMP5.
- Experience defending application validation documentation in front of inspectors from Regulatory Authorities.
You are a strong team player, analytical, and have a can-do attitude.
You possess an agile and entrepreneurial mindset and can thrive in an informal, open environment where innovation, collaboration and change are key.
To succeed in this role, we expect you to possess strong technical skills, to be detail-orientated and at the same time have a strong focus on how to create value with the business to help patients.
Travel: 15 - 20 days per year.
Office: Hellerup, Denmark or Palo Alto, California, United States.
Applications will be evaluated when received, so please apply as soon as possible.
All applications must be submitted in English and are treated confidentially.
For more details about the position or the company, please contact Ivanna Rosendal on firstname.lastname@example.org or Lene Larsen on email@example.com or visit our website www.ascendispharma.com