id: NDkwMTM3MyA3

reference: 4901373

documentId: 4901373

connectionPointId: 7

lastModificationDate: 1541495174843

stillingsbetegnelse:
Global Safety Specialist in Global Safety Operations, Innovative

jobbeskrivelse:

Join a successful and growing company with a friendly and positive working atmosphere

If you have a solid understanding of guidelines across EMA/ICH/FDA/GCP, and you are looking for a job with great variety of tasks and global vision, you don’t have to look any further. At LEO you will be part of a successful and rapidly growing company, and you will join a well-functioning department known for team spirit, cooperation and genuine care for each other.

Today, 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. And this is where you enter the scene. By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our common quest to become the preferred dermatology care partner improving people’s lives around the world.

 

Ensure high quality case handling and processes

Without strong drug safety focus, LEO would not exist for long, and when we are growing globally our area of expertise – and your presence – becomes yet more important. As Global Safety Specialist in Global Safety, Innovative, your primary focus is to ensure timely handling of clinical trial cases arising from LEO sponsored clinical trials worldwide an in terms of case receipt, data entry and submission/distribution according to legislation governing this area worldwide and maintain a high compliance in relation to legislation worldwide. In overview your primary tasks will be to:

• Maintain quality documents and processes (both for post marketing and clinical trials)
• Handle adverse event cases in a validated IT system
• Distribute/submit clinical trial cases and distribute/submit these accordingly 
• SAE reconciliation and reconciliation of cases with affiliates and partners
• Quality check and review
• Manage the mailbox of pharmacovigilance enquiries
• Participate in trial team meetings 
• MedDRA coding

You will be in daily contact with affiliates and will be working closely together with colleagues in New York and our partner in India. As such, a vital path to your success will be to establish strong relations to a large number of people internally and externally.

 

Knowledge of safety databases

Your theoretical background is a degree within health science. This is backed by hands-on experience from working with EMA/ICH/FDA/GCP guidelines that also has provided you with computer literacy and knowledge of safety databases. If you additionally have experience within ARISg it will be an advantage but not a prerequisite to apply.

To succeed, you must possess solid analytical skills in order to interpret data and have the ability to communicate complex medical terminologies in a logical and easy understandable way, written and spoken in high-level English. As you will have many contacts across geography, professions and cultures you will need all of your positive and open-minded approach, including the ability to understand a challenge from the perspective of the person you interact with. Finally, you must like to take proactive action when needed and ensure a solid completion of a task at hand.

 

Global Pharmacovigilance – your new department

You will join 28 skilled and dedicated specialists based in DK (13), the US (5) and India (10). Together we handle adverse events for LEO Pharma globally. High quality, attention to details and willingness to help each other is key to us. You will be part of the Danish team at our headquarters in Ballerup, Greater Copenhagen.

We look forward to receiving your application.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2131

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR