Senior Principal Professional /Global Safety Standards and Compliance/Deputy QPPV
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Ballerup
Are you experienced in all aspects of pharmacovigilance (PV), and are you able to apply this knowledge to solve issues? Can you build strong relationships and guide other experienced PV colleagues? Are you able to improve the efficiency and compliance of the pharmacovigilance system while ensuring the quality and safety of the medicinal products? LEO Pharma is looking for a deputy QPPV, who can, in collaboration with the QPPV, provide this!
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 PV 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 act as senior back-up for the QPPV. You will be acting QPPV in the absence of LEO Pharma’s EU QPPV and assume the full responsibility for delegated tasks. In addition, you will be accountable for the improvement and maintenance of LEO Pharma Pharmacovigilance System Master File (PSMF) and member of LEO Pharma’s Global Review Committee for non-interventional studies (NIS) and investigator-initiated studies (IIS).
Act as deputy QPPV, when delegated by the QPPV.
In daily work, the QPPV, the deputy QPPV and the QPPV Officer will partner and share the work.
In accordance with Good Vigilance Practice (GVP), the overall objective for the QPPV is:
Delegated tasks
In this role you will be responsible for delegated QPPV tasks in relation to LEO Pharma product portfolio and PV system, e.g.
Support to the organization
Pharmacovigilance System Master File
Global Review Committee for non-interventional studies (NIS) and investigator-initiated studies (IIS)
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, at + 45 5379 8853.
. Send your application to us as soon as possible and no later than 5. October 2020 as we’ll be conducting interviews on a continuous basis.
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. Read more at 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. If you have experience in quality management, implementation and maintenance of global PV 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 act as senior back-up for the QPPV. You will be acting QPPV in the absence of LEO Pharma’s EU QPPV and assume the full responsibility for delegated tasks. In addition, you will be accountable for the improvement and maintenance of LEO Pharma Pharmacovigilance System Master File (PSMF) and member of LEO Pharma’s Global Review Committee for non-interventional studies (NIS) and investigator-initiated studies (IIS).
Act as deputy QPPV, when delegated by the QPPV.
In daily work, the QPPV, the deputy QPPV and the QPPV Officer will partner and share the work.
In accordance with Good Vigilance Practice (GVP), the overall objective for the QPPV is:
- To establish and maintain the LEO Pharma global PV system, including establishment and maintenance of the PSMF
- To maintain an overview of the safety profile, and any emerging safety concerns of marketed products
- To act as a single point of contact for competent authorities on a 24-hour basis
Delegated tasks
In this role you will be responsible for delegated QPPV tasks in relation to LEO Pharma product portfolio and PV system, e.g.
- Review of documents related to delegated LEO medicinal products
- Review of QMS documents
- Support to audits and inspections
Support to the organization
- Participate in defining the strategy for Global Safety Standards and Compliance
- Act as senior professional with experience in all aspects of pharmacovigilance
- Guide and support colleagues the global PV organization including experienced PV professionals and managers
- Lead and support GS improvement and compliance initiatives
Pharmacovigilance System Master File
- Process owner of the PSMF
Global Review Committee for non-interventional studies (NIS) and investigator-initiated studies (IIS)
- GS member of the committee, ensuring adherence to PV regulations and internal processes
Your qualifications
- MD, pharmacist or degree in health sciences
- Profound experience within the pharmaceutical industry
- Solid pharmacovigilance knowledge and able to apply this knowledge and solve problems in new areas in a risk-based manner
- Ability to significantly influence and lead functional initiatives with an organization-wide impact
- Be involved in several projects, deal with multiple priorities and impact decisions significantly
- Train and develop other experienced PV professionals across teams in the discipline
- Communicate critical and/or complex results, ideas or visions
- Have a global perspective – think strategic and challenge status quo
- Has excellent communication and influencing skills and demonstrated credibility when partnering with functions across LEO Pharma; ability to present strategies, policy & work processes
- Driver for improvements, flexible thinker, to enable resourcefulness in issue resolution, decision-making and integration of new PV quality systems
- Strong relationship builder - ability to work with PV partners across global boundaries e.g. affiliates and pers in industry
- Good knowledge of computers, common computer programs and databases
- Good IT skills and experienced user of common Microsoft Office programs
- Proficient in verbal and written English
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 5. October 2020 as we’ll be conducting interviews on a continuous basis.
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. Read more at 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 8.9.2020, 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 05. oktober 2020
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