System & Application Manager for Global Pharmacovigilance & Clinical Development
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Hørsholm
Do you thrive in a dynamic atmosphere? Are you eager to take on an exciting position with a high degree of individual responsibility?
The position
You will as System & Application Manager join the System & Application department and be part Global Pharmacovigilance & Clinical Development (GPCD). We are four engaged team members in the System & Application team all located at the ALK headquarter in Hørsholm. The department is responsible for the maintenance, development and continuous improvement of the IT systems used in GPCD.
The IT systems are both cloud-based/on-premises and includes the Global Safety Database (Argus), CTMS system, HALO and BI-Tools. In addition, the department is also assisting in cross organisational projects as well as projects with external partners. Apart from our stakeholders in GPCD, the System & Application team work closely together with our Quality Assurance department and Global IT Department.
Your main responsibility is to contribute to the maintenance, development, and continuous improvements of the GPCD IT systems to ensure functionality and compliance. The primary focus will be the ALK Global Safety Database, Argus Safety.
You will also be participating in implementation of changes to existing systems and/or initiation of new systems and are expected to give subject matter expert input regarding regulatory requirements, business processes and validation requirements. You will be included in all levels of the projects, from task management to documentation of informal and formal testing. You will also be included in updating and maintaining standard operating procedures or guidelines, supporting and training of end-users and act as a point of entry for the Global IT department (GBIT).
Your profile
Preferably you have experience working with a safety database (Business configuration/Advanced business configuration) or similar. You are experienced with IT system testing, validation requirements and documentation, impact assessment and stakeholder management.
This role requires a structured approach and analytical skills including the ability to focus on details and adherence to standards, while maintaining a balanced business perspective. The capability to understand and connect regulatory requirements, business processes and functionality of IT systems is essential.
Furthermore, we expect:
You show initiative and flexibility and have a good sense of humour. You are open-minded and enthusiastic, a strong team player who can take responsibility and drive assignments. You are fluent in both written and spoken English on a professional level and feel comfortable working with colleagues from different cultural backgrounds.
Become a part of ALK
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
Joining our team, you will work in an informal, fast-paced atmosphere with multiple global stakeholders across ALK reflecting the increasing demands from clinical trials and regulatory authority requirements.
The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. We consider our pioneering spirit coupled with our trustworthiness our winning formula. Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm.
Contact
Do you want to learn more about our company, we encourage you to visit us at www.alk.net. If you want to know more about the position before submitting your application, please refer your questions to Michael Kristensen, Associate Director of GPCD Systems & Applications on telephone +45 50 89 95 71.
The position
You will as System & Application Manager join the System & Application department and be part Global Pharmacovigilance & Clinical Development (GPCD). We are four engaged team members in the System & Application team all located at the ALK headquarter in Hørsholm. The department is responsible for the maintenance, development and continuous improvement of the IT systems used in GPCD.
The IT systems are both cloud-based/on-premises and includes the Global Safety Database (Argus), CTMS system, HALO and BI-Tools. In addition, the department is also assisting in cross organisational projects as well as projects with external partners. Apart from our stakeholders in GPCD, the System & Application team work closely together with our Quality Assurance department and Global IT Department.
Your main responsibility is to contribute to the maintenance, development, and continuous improvements of the GPCD IT systems to ensure functionality and compliance. The primary focus will be the ALK Global Safety Database, Argus Safety.
You will also be participating in implementation of changes to existing systems and/or initiation of new systems and are expected to give subject matter expert input regarding regulatory requirements, business processes and validation requirements. You will be included in all levels of the projects, from task management to documentation of informal and formal testing. You will also be included in updating and maintaining standard operating procedures or guidelines, supporting and training of end-users and act as a point of entry for the Global IT department (GBIT).
Your profile
Preferably you have experience working with a safety database (Business configuration/Advanced business configuration) or similar. You are experienced with IT system testing, validation requirements and documentation, impact assessment and stakeholder management.
This role requires a structured approach and analytical skills including the ability to focus on details and adherence to standards, while maintaining a balanced business perspective. The capability to understand and connect regulatory requirements, business processes and functionality of IT systems is essential.
Furthermore, we expect:
- B.Sc. or M.Sc within nature science or similar.
- Minimum 4-5 years of experience within Clinical or Pharmacovigilance regulated areas.
- Ability to independently manage and drive complex system tasks.
- A team player with good analytical skills and quality-oriented mindset.
- Ability to understand various stakeholder needs whilst maintaining objectivity.
You show initiative and flexibility and have a good sense of humour. You are open-minded and enthusiastic, a strong team player who can take responsibility and drive assignments. You are fluent in both written and spoken English on a professional level and feel comfortable working with colleagues from different cultural backgrounds.
Become a part of ALK
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
Joining our team, you will work in an informal, fast-paced atmosphere with multiple global stakeholders across ALK reflecting the increasing demands from clinical trials and regulatory authority requirements.
The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. We consider our pioneering spirit coupled with our trustworthiness our winning formula. Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm.
Contact
Do you want to learn more about our company, we encourage you to visit us at www.alk.net. If you want to know more about the position before submitting your application, please refer your questions to Michael Kristensen, Associate Director of GPCD Systems & Applications on telephone +45 50 89 95 71.
Information og data
Denne ledige stilling har jobtypen "Frontendudvikler", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 23.3.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Frontendudvikler
- Hørsholm
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