Global Safety Surveillance Associate
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Ballerup
Can you stay organised and handle complex documents?
Are you able to handle business critical pharma documents and do you have a high-level command of English supplemented by very good organisational skills? Do you also want to join a successful company, dedicated towards fulfilling the vision of becoming the world’s preferred dermatology partner? Then you may be the one we are looking for.
Tasks and responsibilities
You will assist the Global Safety Surveillance (GSS) product safety teams in planning their various reports. You will collect data and information from departments outside GSS, provide document support and retrieve data from the global safety database. In corporation with the product safety teams you prepare submission ready safety documents which meet regulatory requirements and you file and handle the documents in our electronic data management system.
Your primary tasks are a good and varied mix of document support and document management tasks:
Plan, coordinate, gather and compile information for safety documents, e.g. PSURs, DSURs, RMPs Create documents according to the LEO indexing instruction Perform technical quality control of reports and documents as per set instructions Pull out line listings and summary tabulations from the Global Safety database (ARISg) Maintain the schedule for periodic and ad-hoc safety reports Distribute reports and supporting documents to obtain internal review and approvals Perform exposure calculations based on extracted sales data from e.g. SAP Perform quality compliance tracking of documents submitted to authorities Keeping WORD templates up to date and in compliance to submission readiness
Strong organiser with solid communication skills and excellent English
As a minimum you have a bachelor’s degree or equivalent/relevant education, preferably with a minimum of 3 years from working in a regulated industry, e.g. pharma or food. Regardless of your background, you must bring a solid command of written and oral English and very good communication skills. Just as important are your high level of organisational skills including your excellent attention to detail and document quality. You like to take on responsibility, you work in a structured manner and you are committed, helpful and flexible. You have an excellent overall understanding of IT-systems/programmes, and you are eager to learn more.
On a personal level you are good humoured with a positive mindset, persistent in completing the tasks at hand, and appreciates being in contact with many colleagues across sections and departments.
As you will be part of a fast-paced environment with many deadlines, and you will carry out many tasks simultaneously, you must be good at multitasking and prioritising. Additionally, you must be able to work independently as well as part of a team. Finally, you must be able to adapt to regular changes in processes, routines and ways of working.
Are you able to handle business critical pharma documents and do you have a high-level command of English supplemented by very good organisational skills? Do you also want to join a successful company, dedicated towards fulfilling the vision of becoming the world’s preferred dermatology partner? Then you may be the one we are looking for.
Tasks and responsibilities
You will assist the Global Safety Surveillance (GSS) product safety teams in planning their various reports. You will collect data and information from departments outside GSS, provide document support and retrieve data from the global safety database. In corporation with the product safety teams you prepare submission ready safety documents which meet regulatory requirements and you file and handle the documents in our electronic data management system.
Your primary tasks are a good and varied mix of document support and document management tasks:
Strong organiser with solid communication skills and excellent English
As a minimum you have a bachelor’s degree or equivalent/relevant education, preferably with a minimum of 3 years from working in a regulated industry, e.g. pharma or food. Regardless of your background, you must bring a solid command of written and oral English and very good communication skills. Just as important are your high level of organisational skills including your excellent attention to detail and document quality. You like to take on responsibility, you work in a structured manner and you are committed, helpful and flexible. You have an excellent overall understanding of IT-systems/programmes, and you are eager to learn more.
On a personal level you are good humoured with a positive mindset, persistent in completing the tasks at hand, and appreciates being in contact with many colleagues across sections and departments.
As you will be part of a fast-paced environment with many deadlines, and you will carry out many tasks simultaneously, you must be good at multitasking and prioritising. Additionally, you must be able to work independently as well as part of a team. Finally, you must be able to adapt to regular changes in processes, routines and ways of working.
Information og data
Denne ledige stilling har jobtypen "Sikkerhedsmedarbejder", og befinder sig i kategorien "Kontor, handel og service".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 3.9.2019, 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.
- Sikkerhedsmedarbejder
- Ballerup
- Tirsdag den 24. september 2019
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