EU Qualified Person for Pharmacovigilance (QPPV)
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An exciting and impactful job opportunity at Director level in Global Safety
In Global Safety you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and we need you. You will enter LEO Pharma at the most exciting period of times, where we apply a science- and riskbased approach to maintain our mature products while expanding our focus to be at the forefront of scientific advancements within dermatology including new biologic treatments and combination products.
The job
As EU QPPV you will have the ultimate accountability for LEO Pharma’s Global pharmacovigilance (PV) system to ensure global regulatory compliance for all LEO Pharma’s marketed products in accordance with Good Pharmacovigilance Practice (GVP).
You will have a key role in the governance and associated decision making of safety/risk manage-ment of LEO Pharma’s products as member of LEO Pharma’s Safety Review Board (SRB), other governance bodies, and the Global Safety Leadership Team (GSLT). Together with the GSLT you will set the vision and future direction LEO Pharma’s PV organization. You will partner with the deputy QPPV and report to the VP, Head of Global Safety.
Overall objectives:
To optimise and maintain LEO Pharma’s Global PV system, including scoping and approving the Pharmacovigilance System Master File (PSMF) To review and maintain an overview of the safety profile, and any emerging safety concerns, of all LEO Pharma’s clinical and marketed products To act as a single point of contact for Competent Authorities on a 24hour basis
Your qualifications:
MD, Pharmacist or other relevant degree in Health Sciences Preferably previous QPPV and/or deputy QPPV experience +10 years of PV experience including extensive knowledge in Global PV legislation and guidance, local PV requirements, audits/inspections, technical understanding, medical writing
As QPPV it is imperative that you are agile in building partnerships and work collaboratively with stakeholders, but also that you can assert your authority when required. It is equally important that you can communicate clearly and understand the unique needs of different audiences and that you can manoeuvre comfortably through complex policies, processes, and people-related organizational dynamics. A compliant mindset with an innovative, pragmatic, and risk-based approach is a must.
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.
In Global Safety you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and we need you. You will enter LEO Pharma at the most exciting period of times, where we apply a science- and riskbased approach to maintain our mature products while expanding our focus to be at the forefront of scientific advancements within dermatology including new biologic treatments and combination products.
The job
As EU QPPV you will have the ultimate accountability for LEO Pharma’s Global pharmacovigilance (PV) system to ensure global regulatory compliance for all LEO Pharma’s marketed products in accordance with Good Pharmacovigilance Practice (GVP).
You will have a key role in the governance and associated decision making of safety/risk manage-ment of LEO Pharma’s products as member of LEO Pharma’s Safety Review Board (SRB), other governance bodies, and the Global Safety Leadership Team (GSLT). Together with the GSLT you will set the vision and future direction LEO Pharma’s PV organization. You will partner with the deputy QPPV and report to the VP, Head of Global Safety.
Overall objectives:
Your qualifications:
As QPPV it is imperative that you are agile in building partnerships and work collaboratively with stakeholders, but also that you can assert your authority when required. It is equally important that you can communicate clearly and understand the unique needs of different audiences and that you can manoeuvre comfortably through complex policies, processes, and people-related organizational dynamics. A compliant mindset with an innovative, pragmatic, and risk-based approach is a must.
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.
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 1.8.2019, 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.
- Kemiker
- Ballerup
- Lørdag den 31. august 2019
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