Senior Professional /Pharmacovigilance Compliance Specialist
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Ballerup
Have you experience in managing PV audits & inspections? Are you passionate about efficient global pharmacovigilance Quality Management Systems? then you might be the new colleague we are looking for!
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. In LEO Pharma you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
In this senior PV Specialist position, you get to work with different aspects of the pharmacovigilance (PV) Quality Management System (QMS) together with a great team of dedicated and skilled PV professionals in Global Safety Standards and Compliance.
PV Audits, Inspections, and Deviations
PV Quality Management System (QMS) Documents
PSMF Management
Other GSSC tasks
Your qualifications
Your new team
This is an interesting job with great opportunities for both personal and professional development. You will be working in an international and cross-disciplinary environment, and you can look forward to becoming part of a dedicated team, who uphold a great working environment. You will be located in Ballerup, and report into the EU QPPV, Head of Global Safety Standards and Compliance.
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 Berit Nautrup Andersen, Director, QPPV, Head of Global Safety Standards and Compliance, at + 45 5379 8853. . Send your application to us as soon as possible and no later than 18th. October 2021.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,400 people worldwide. For more information, visit www.leo-pharma.com.
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. In LEO Pharma you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
In this senior PV Specialist position, you get to work with different aspects of the pharmacovigilance (PV) Quality Management System (QMS) together with a great team of dedicated and skilled PV professionals in Global Safety Standards and Compliance.
PV Audits, Inspections, and Deviations
- In collaboration with Global QA coordinate and prepare for internal audits and external Health Authority inspections – for GS, affiliates and partners
- Support GS during internal audits (part of back office and auditee)
- Oversee and follow-up on performance of audit and inspection CAPA management within GS
- Implement, document, and analyze the PV audit process and CAPA Management and to translate into new or improved PV processes
- Manage delegated deviation reports in MyQMS, including monitoring and follow-up with the responsible functional area to ensure timely closure of deviation reports.
PV Quality Management System (QMS) Documents
- Develop and manage the process for PV QMS Documents (i.e. Standard Operating Procedures, Work Instructions and Enclosures) in accordance with LEOs overall strategy
- Collaborate with authors to ensure that GS QMS Documents are adhering to the process and templates, and provide guidance and input, where relevant
- Maintain the oversight of QMS documents for the PSMF
- Contribute to the maintenance of GS SOP matrix
PSMF Management
- Develop and maintain a GS process the generation, oversight and archiving of regulatory documents requested for registrations and renewals (e.g. QPPV Guarantee Letters and PSMF documents)
- Develop and maintain oversight and review of local PSMFs
- Support the maintenance of the EU and UK PSMF, if required
Other GSSC tasks
- Daily surveillance of GSSC shared mailboxes
- Drive tasks of high complexity in internal or cross-functional projects, as delegated
- Develop or improve procedures within area of responsibility
Your qualifications
- Pharmacist, other relevant Degree in Health Sciences or equivalent
- Extensive experience within the pharmaceutical industry
- Solid Pharmacovigilance knowledge
- Strong quality mindset
- Good communication skills
- Structured and detail oriented
- Able to set the direction and deliver results
- Independently make solve common issues and make improvements to systems within the area of responsibility
- Ability to guide and train other senior colleagues and managers
- Proficient in verbal and written English
- Good IT skills and experienced user of common Microsoft Office programs
Your new team
This is an interesting job with great opportunities for both personal and professional development. You will be working in an international and cross-disciplinary environment, and you can look forward to becoming part of a dedicated team, who uphold a great working environment. You will be located in Ballerup, and report into the EU QPPV, Head of Global Safety Standards and Compliance.
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 Berit Nautrup Andersen, Director, QPPV, Head of Global Safety Standards and Compliance, at + 45 5379 8853. . Send your application to us as soon as possible and no later than 18th. October 2021.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,400 people worldwide. For more information, visit www.leo-pharma.com.
Information og data
Denne ledige stilling har jobtypen "Kemiker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 31.8.2021, 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.
- Kemiker
- Ballerup
- Mandag den 18. oktober 2021
Lignende jobs
-
Kemiker i Storkøbenhavn
I stillingen vil du få fagligt ansvar for en række farmaceutiske analyser, hvor du vil komme til at arbejde med kvalitetssikring samt optimering og udvikling af metoder. Da vi anvender en lang rækk..Få mere info- Kemiker
- Storkøbenhavn
-
Kemiker i Storkøbenhavn
Har du en kemisk uddannelse på kandidatniveau? Kommer du i godt humør af den faglige dialog? Kan du se charmen i at veksle mellem dage med varierede driftsopgaver og fokuserede dage med projektopga..Få mere info- Kemiker
- Storkøbenhavn
-
Kemiker i Herlev
Har du en kemisk uddannelse på kandidatniveau? Kommer du i godt humør af den faglige dialog? Kan du se charmen i at veksle mellem dage med varierede driftsopgaver og fokuserede dage med projektopga..Få mere info- Kemiker
- Herlev
-
Kemiker i Herlev
Jobbet Vi søger en medarbejder til et 1-årigt barselsvikariat til produktion af radioaktive lægemidler i cyklotronlaboratoriet på Afdeling for Nuklearmedicin på [xxxxx] Cyklotronlabo..Få mere info- Kemiker
- Herlev
Statistik over udbudte jobs som kemikere i Ballerup
Herunder ser du udviklingen i udbudte kemiker i Ballerup over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal kemikere.
Se flere statistikker her:
Statistik over udbudte kemikere i Ballerup over tid
| Dato | Alle jobs som kemikere |
|---|---|
| 30. juni 2024 | 0 |
| 29. juni 2024 | 0 |
| 28. juni 2024 | 0 |
| 27. juni 2024 | 0 |
| 26. juni 2024 | 0 |
| 25. juni 2024 | 0 |
| 24. juni 2024 | 0 |
| 23. juni 2024 | 0 |
| 22. juni 2024 | 0 |
| 21. juni 2024 | 0 |
| 20. juni 2024 | 0 |
| 19. juni 2024 | 0 |
| 18. juni 2024 | 0 |
| 17. juni 2024 | 0 |
| 16. juni 2024 | 0 |
| 15. juni 2024 | 0 |
| 14. juni 2024 | 0 |
| 13. juni 2024 | 0 |
| 12. juni 2024 | 0 |
| 11. juni 2024 | 0 |
| 10. juni 2024 | 0 |
| 9. juni 2024 | 0 |
| 8. juni 2024 | 0 |
| 7. juni 2024 | 0 |
| 6. juni 2024 | 0 |
| 5. juni 2024 | 0 |
| 4. juni 2024 | 0 |
| 3. juni 2024 | 0 |
| 2. juni 2024 | 0 |
| 1. juni 2024 | 0 |
| 31. maj 2024 | 0 |