Senior Professional /Global Safety Standards and Compliance
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Ballerup
Are you passionate about quality management and efficient global pharmacovigilance systems?
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 have experience in quality management, implementation and maintenance of global pharmacovigilance systems in the affiliates, then you may be our new colleague. In Global Safety Standards and Compliance, you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
In this position you will get an opportunity to influence the strategy for and implementation of a harmonized global pharmacovigilance system across LEO Pharma affiliates and other local entities. In addition, you will be building the bridge between the global and local pharmacovigilance system by being responsible for maintaining the oversight and provide support to the quality management and compliance tracking in relation to local pharmacovigilance systems.
Manage contracts with the affiliates and maintain contact lists
- Maintain the pharmacovigilance contracts with the affiliates
- Maintain the Safety Contact Person (SCP) contact lists, e.g. to be included in the Pharmacovigilance System Master File
Building the bridge between global and local pharmacovigilance
- Be a point of contact for the affiliates and other local entities working on behalf of LEO Pharma for request related to the pharmacovigilance system
- Work collaboratively in the matrix organization with other Global Safety functions in supporting the affiliates and other local entities working on behalf of LEO Pharma
Local pharmacovigilance requirements
- Ensure that national ICSR reporting requirements or other local safety related requirements are implemented in LEOs global pharmacovigilance system
- Maintain the GS systems for products, local pharmacovigilance requirements, and split of responsibilities between Affiliates/Area offices and LEO Pharma partners
PV Quality Documents
- Lead the implementation and maintenance of a harmonized PV process across the affiliates and other local entities working on behalf of LEO Pharma
Audits, Inspections and deviations
- Support to LEO Global QA before, during and after pharmacovigilance audits
- Coordinate Global Safety support before, during and after local inspections
- Global Safety management and oversight of local deviation reports
- Global Safety management and oversight of local CAPAs
Compliance
- Compilation and management of data and documents for Global Safety compliance monitoring
Enable the business
- Support the EU QPPV in providing QPPV/PSMF documents for renewals as required locally
- Support the establishment of a QPPV Board to ensure efficient support to local QPPVs
Your qualifications
- A scientific educational background or equivalent
- Minimum 8 years’ experience within the pharmaceutical industry
- Solid Pharmacovigilance knowledge
- A strong quality mindset
- Good communication skills
- Structured and detail oriented
- 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, at + 45 5379 8853.
. Send your application to us as soon as possible and no later than 16. August, 2020 as we’ll be conducting interviews on a continuous basis.
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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 27.7.2020, 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
- Søndag den 16. august 2020
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