Drug Safety Specialist - Global Safety Operations Established
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Ballerup
Do you have an educational background within health sciences such as Nurse or Pharmacist? Join a successful company with a friendly and positive work atmosphere
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. If you are looking for a job with great variety of tasks and a global vision, you don’t have to look any further. In Global Safety Operations Established (GSOe) team spirit, cooperation and genuine care for each other are key words.
Ensure high quality
A strong pharmacovigilance department is crucial for LEO Pharma´s success. In GSOe, drug safety is our focus. As Global Safety Specialist in GSOe, your primary focus will be to make sure that Individual Case Study Reports (ICSRs) are processed timely and according to PV legislation to maintain a high compliance in relation to PV legislation worldwide.
Your primary daily task will be handling of ICSRs reported for LEO Pharma marketed products globally. After relevant training, you must be able to perform your daily tasks with a minimum of supervision. This includes (but not limited to):
- Duplicate search
- Causality assessment
- Listedness assessment
- MedDRA coding
- Case narrative writing
- Conduct follow-up on ICSRs
- Timely submission of ICSRs to competent authorities, partners and affiliates
You will be in daily contact with affiliates and colleagues worldwide. As such, a vital path to your success will be to establish strong relations to many people internally in the LEO Pharma organization as well as externally.
Your qualifications
Your educational background is a degree within health sciences, e.g. as a Nurse or a Pharmacist. Hands-on experience with ICSR case handling is an advantage.
To succeed you must possess solid analytical skills in order to interpret data and be able to communicate complex medical terminologies in a logical and easy understandable way, written and spoken, in English at academic level. You will have many contacts across geographies professions and cultures. Therefore, you must have a positive and open-minded approach, including the ability to understand a challenge from the perspective of the person you interact with. You have an inner drive that urges you to learn and be curious. You are a team player and thrive on receiving and giving feed-back. Finally, you must enjoy taking proactive action when needed and ensure a solid and timely completion of tasks at hand.
Global Safety Operations, Established – your new department
You will join a skilled, dedicated, humorous and helpful specialist team. High quality, attention to details and willingness to help each other is our keys to success.
GSOe is placed at LEO Pharma´s headquarter in Ballerup, Greater Copenhagen Area.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Manager, Thea Ellermann Petersen at + 45 3117 5839.
. The deadline is 11 January 2021. Interviews will be held on an ongoing basis until we have found the right candidate to join our great team.
About LEO Pharma
At LEO Pharma, we are pioneering together. We help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology. Each one of us at LEO Pharma can make a real impact in our everyday work. Together, we explore new ideas and make them happen. We do this through mutual respect and a shared sense of purpose, rooted in our caring culture and a commitment to helping others. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. If you are looking for a job with great variety of tasks and a global vision, you don’t have to look any further. In Global Safety Operations Established (GSOe) team spirit, cooperation and genuine care for each other are key words.
Ensure high quality
A strong pharmacovigilance department is crucial for LEO Pharma´s success. In GSOe, drug safety is our focus. As Global Safety Specialist in GSOe, your primary focus will be to make sure that Individual Case Study Reports (ICSRs) are processed timely and according to PV legislation to maintain a high compliance in relation to PV legislation worldwide.
Your primary daily task will be handling of ICSRs reported for LEO Pharma marketed products globally. After relevant training, you must be able to perform your daily tasks with a minimum of supervision. This includes (but not limited to):
- Data entry of ICSRs into our safety data base ARISg which includes:
- Duplicate search
- Causality assessment
- Listedness assessment
- MedDRA coding
- Case narrative writing
- Conduct follow-up on ICSRs
- Timely submission of ICSRs to competent authorities, partners and affiliates
- Handle adverse events related to customer complaints
- Perform Quality Review of your colleague’s cases
- Maintain quality documents and quality processes for post marketing products
- Manage Global Safety´s shared mailbox of pharmacovigilance enquiries
You will be in daily contact with affiliates and colleagues worldwide. As such, a vital path to your success will be to establish strong relations to many people internally in the LEO Pharma organization as well as externally.
Your qualifications
Your educational background is a degree within health sciences, e.g. as a Nurse or a Pharmacist. Hands-on experience with ICSR case handling is an advantage.
To succeed you must possess solid analytical skills in order to interpret data and be able to communicate complex medical terminologies in a logical and easy understandable way, written and spoken, in English at academic level. You will have many contacts across geographies professions and cultures. Therefore, you must have a positive and open-minded approach, including the ability to understand a challenge from the perspective of the person you interact with. You have an inner drive that urges you to learn and be curious. You are a team player and thrive on receiving and giving feed-back. Finally, you must enjoy taking proactive action when needed and ensure a solid and timely completion of tasks at hand.
Global Safety Operations, Established – your new department
You will join a skilled, dedicated, humorous and helpful specialist team. High quality, attention to details and willingness to help each other is our keys to success.
GSOe is placed at LEO Pharma´s headquarter in Ballerup, Greater Copenhagen Area.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Manager, Thea Ellermann Petersen at + 45 3117 5839.
. The deadline is 11 January 2021. Interviews will be held on an ongoing basis until we have found the right candidate to join our great team.
About LEO Pharma
At LEO Pharma, we are pioneering together. We help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology. Each one of us at LEO Pharma can make a real impact in our everyday work. Together, we explore new ideas and make them happen. We do this through mutual respect and a shared sense of purpose, rooted in our caring culture and a commitment to helping others. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 16.12.2020, 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.
- Øvrige
- Ballerup
- Mandag den 11. januar 2021
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